Review Panel
Cardiovascular FDA 510(k) Clearances & Devices
- Cleared Devices
- 19,212
- Product Codes (page)
- 50
- Latest Decision
- 2024-12-10
Clearances · page 8 of 193
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K241521 | Prelude Small O.D. Introducer Guide Wire | Merit Medical Systems, Inc. | DQX | Class II | 2024-12-10 |
| K242451 | HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta- monitor pressure cable (HEMAPSC200);Acumen AFM cable- HemoSphere Alta monitor (HEMAFM100) | Edwards Lifesciences | DYG | Class II | 2024-12-09 |
| K240971 | 87 NeuGlide Catheter | Piraeus Medical | QJP | Class II | 2024-12-06 |
| K242824 | PTFE Guidewire | Lake Region Medical | DQX | Class II | 2024-12-06 |
| K243435 | Magnetic Localization Patch Kit (AFR-00021) | Medtronic, Inc. | DQK | Class II | 2024-12-05 |
| K243180 | SSPC NXT Delivery Catheter | CenterPoint Systems, LLC | DQY | Class II | 2024-12-04 |
| K241197 | DeepRhythmAI | Medicalgorithmics S.A. | DQK | Class II | 2024-12-04 |
| K242301 | Socrates 38 Catheter | Scientia Vascular, Inc. | QJP | Class II | 2024-12-04 |
| K241090 | Evie Med Ring | Movano Inc. Dba Movano Health | DQA | Class II | 2024-11-29 |
| K242225 | Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic Catheter | Surgical Instrument Service and Savings, Inc. | NLH | Class II | 2024-11-29 |
| K243118 | Arm Blood Pressure Monitor (model: BPM-A7VL) | Shenzhen Imdk Medical Technology Co., Ltd. | DXN | Class II | 2024-11-26 |
| K243193 | Cross Wise Multi-Use RF Adapter Cable | Circa Scientific, Inc. | DXF | Class II | 2024-11-26 |
| K240818 | R2P Radifocus Glidewire Advantage | Terumo Corporation | DQX | Class II | 2024-11-26 |
| K241851 | Versus Catheter (VS110-8B) | Liquet Medical, Inc. | QEY | Class II | 2024-11-25 |
| K242971 | AccurSound Electronic Stethoscope (AS101) | Heroic Faith International , Ltd. | DQD | Class II | 2024-11-25 |
| K232520 | Fingertip Pulse Oximeter, models Alpine20, Alpine20A, Alpine20H, Alpine20HA, Alpine20B, Alpine20BA, Alpine20BH, Alpine20BHA, Alpine30, Alpine30A, Alpine30H, Alpine30HA, Alpine30B, Alpine30BA, Alpine30BH, Alpine30BHA, Alpine20L, Alpine20LB, Alpine20LH, Alpine20LBH, Alpine30L, Alpine30LB, Alpine30LH, Alpine30LBH | Shenzhen Smallsignal Technology Co., Ltd. | DQA | Class II | 2024-11-21 |
| K242520 | Element Vascular Access System | Penumbra, Inc. | DYB | Class II | 2024-11-20 |
| K240746 | Neurovascular Access System Family | Q'Apel Medical, Inc. | QJP | Class II | 2024-11-20 |
| K240871 | Synxess Neurovascular Guidewire | Enlight Medical Technologies (Shenzhen) Co., Ltd. | MOF | Class II | 2024-11-18 |
| K242092 | MICRO Arterial Filters | Sorin Group Italia S.R.L. | DTM | Class II | 2024-11-18 |
| K241633 | Informed Vital Core Application (IVC App) | Mindset Medical, Inc. | QME | Class II | 2024-11-18 |
| K241070 | Gelsoft Plus Vascular Prostheses | Vascutek, Ltd. | DSY | Class II | 2024-11-15 |
| K241224 | Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Auto ID Technology (BD710DF282CT, BD710DF282RTS, BD710FJ282RTS, BD710FJ282CT) | Surgical Instrument Service and Savings Inc.(Dba Medline Ren | NLH | Class II | 2024-11-15 |
| K242419 | 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter | Creagh Medical Ltd. Dba Surmodics, Inc. | LIT | Class II | 2024-11-15 |
| K240860 | EchoGo Amyloidosis (1.0) | Ultromics Limited | SDJ | Class II | 2024-11-15 |
| K241397 | Hinscope | Hinlab Sas | MSX | Class II | 2024-11-14 |
| K211498 | Nonin OTC Pulse Oximeter Model 3250 | Nonin Medical, Inc. | OLK | Class II | 2024-11-13 |
| K242420 | pNOVUS 21 Microcatheter | Phenox, Ltd. | DQO | Class II | 2024-11-12 |
| K242018 | UbiqVue 2A Multi-parameter System (UX2550) | Lifesignals, Inc. | DRG | Class II | 2024-11-12 |
| K243233 | esolution® Esophageal Retractor | S4 Medical Corp. | QXU | Class II | 2024-11-09 |
| K240794 | Frontier X Plus | Fourth Frontier Technologies Pvt, Ltd. | MLO | Class II | 2024-11-08 |
| K242756 | Introducer Sheath (PFlexi00L065, PFlexi00L070, PFlexi00L075, PFlexi00L080, PFlexi00L090, PFlexi30L065, PFlexi30L070, PFlexi30L075, PFlexi30L080, PFlexi30L090, PFlexi45L065, PFlexi45L070, PFlexi45L075, PFlexi45L080, PFlexi45L090, PFlexi60L065, PFlexi60L070, PFlexi60L075, PFlexi60L080, PFlexi60L090) | Pulnovo Medical (Wuxi) Co., Ltd. | DYB | Class II | 2024-11-08 |
| K240997 | Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire | ABBOTT MEDICAL | DQX | Class II | 2024-11-06 |
| K241849 | MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2) | Imaxeon Pty, Ltd. | IZQ | Class II | 2024-11-05 |
| K242947 | FreedomFlow Orbital Circumferential Atherectomy System | Cardio Flow Inc., | MCW | Class II | 2024-11-05 |
| K243061 | SonoStik Guide Wire Introducer | Sonostik, LLC | DYB | Class II | 2024-11-04 |
| K241828 | Affera Integrated Mapping System; Impedance Localization Patch Kit | Medtronic, Inc. | DQK | Class II | 2024-11-01 |
| K240366 | EPXT Unidirectional Steerable Diagnostic Catheter; Dynamic Tip Unidirectional Steerable Diagnostic Catheter; Dynamic XT Unidirectional Steerable Diagnostic Catheter | Boston Scientific Corporation | DRF | Class II | 2024-11-01 |
| K242076 | VersaCross RF Wire | Baylis Medical Company | DXF | Class II | 2024-11-01 |
| K242623 | Disposable Blood Pressure cuff; Reusable Blood Pressure cuff | Shenzhen Medke Technology Co., Ltd. | DXQ | Class II | 2024-10-31 |
| K240653 | SmartCardia 7L Platform (MCT) | Smartcardia SA | QYX | Class II | 2024-10-31 |
| K240177 | Zio AT® device (A100A1001) | iRhythm Technologies, Inc. | DSI | Class II | 2024-10-30 |
| K243080 | Riptide Aspiration System | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | NRY | Class II | 2024-10-29 |
| K242969 | Pantera Pro; Pantera LEO | Biotronik, Inc. | LOX | Class II | 2024-10-25 |
| K240092 | Pulse Oximeter (YM101, YM102, YM103, YM104, YM201, YM301, YM202, YM302, YM111, YM112, YM113, YM114, YM211, YM212, YM314, YM601, YM602, YM401, YM402, YM403, YM501, YM502, YM503 and YM504) | Shenzhen Yimi Life Technology Co., Ltd. | DQA | Class II | 2024-10-25 |
| K241007 | Upper Arm Electronic Blood Pressure Monitor (U86E and TelliBP01) | Shenzhen Urion Technology Co., Ltd. | DXN | Class II | 2024-10-24 |
| K242193 | Arm Type Blood Pressure Monitor (BPM82) | Avita Corporation | DXN | Class II | 2024-10-22 |
| K241758 | Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse Oximeter Sensor (4001); Reprocessed RD SET Inf Pulse Oximeter Sensor (4002); Reprocessed RD SET Adt Pulse Oximeter Sensor (4003) | Stryker Sustainability Solutions | NLF | Class II | 2024-10-22 |
| K241478 | Tri-Wedge PTA Scoring Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | PNO | Class II | 2024-10-22 |
| K240029 | Zio AT® device (A100A1001) | iRhythm Technologies, Inc. | QYX | Class II | 2024-10-21 |
| K240711 | Zipline Access Catheter | Perfuze, Ltd. | QJP | Class II | 2024-10-17 |
| K241613 | Elecrtronic Blood Pressure Monitor (BP-201, BP-202, BP-203, BP-204, BP-205, BP-206) | Shenzhen Hbcare Technology Co.,Ltd | DXN | Class II | 2024-10-16 |
| K241244 | CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter | Cerenovus, Inc. | QJP | Class II | 2024-10-16 |
| K241221 | CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing Set | Cerenovus, Inc. | NRY | Class II | 2024-10-16 |
| K242794 | ONCOZENE Microspheres | Varian Medical Systems, Inc. | KRD | Class II | 2024-10-16 |
| K240596 | Cerebral Autoregulation Index (CAI) Algorithm | Edwards Lifesciences | MUD | Class II | 2024-10-16 |
| K241894 | Artix MT; Artix Thin-Walled Thrombectomy Sheath | Inari Medical, Inc. | QEW | Class II | 2024-10-15 |
| K240826 | Reprocessed DECANAV Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar Electrophysiology Catheter | Sterilmed, Inc. | NLH | Class II | 2024-10-11 |
| K240499 | ARTAIRA Arterial Compression Device (AACD01) | Airos Medical, Inc. | JOW | Class II | 2024-10-11 |
| K234110 | Belun Ring BLR-200 (BLR-200) | Belun Technology Company Limited | DQA | Class II | 2024-10-11 |
| K242133 | Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative Positioning System (IOPS®) (Guidewire Handle) | Centerline Biomedical, Inc. | DQK | Class II | 2024-10-11 |
| DEN230076 | Omron Blood Pressure Monitor with Atrial Fibrillation (AFib) Detection Feature (BP7460 (HEM-7371T1-AZ)); Omron Blood Pressure Monitor with Atrial Fibrillation (AFib) Detection Feature (BP5460 (HEM-7372T1-AZAZ)) | Omron Healthcare, Inc. | QXY | Class II | 2024-10-08 |
| K241746 | UMED REPROCESSED AIRCAST VENAFLOW FOOT CUFF; UMED REPROCESSED KENDALL SCD EXPRESS SLEEVE; UMED REPROCESSED AIRCAST ELITE CALF CUFF 3040 3050; UMED REPROCESSED CTC VP 501 CALF CUFF; UMED REPROCESSED CTC VP 520 FOOT CUFF | United Medical Resources, LLC | JOW | Class II | 2024-10-04 |
| K242721 | Upper Arm Electronic Blood Pressure Monitor (FC-BP103, FC-BP106, FC-BP113, FC-BP120, FC-BP121, FC-BP130, FC-BP131) | Shenzhen Finicare Co., Ltd. | DXN | Class II | 2024-10-04 |
| K242106 | AuST Steerable Sheath | CenterPoint Systems, LLC | DYB | Class II | 2024-10-04 |
| K242507 | OBSIDIO Conformable Embolic | Boston Scientific | KRD | Class II | 2024-10-03 |
| K240808 | Pulse Oximeter (WS20A) | Hunan Accurate Bio-Medical Technology Co., Ltd. | DQA | Class II | 2024-10-03 |
| K240529 | 8F Modified Sheath System | Route 92 Medical, Inc. | QJP | Class II | 2024-10-02 |
| K240917 | Esperance 3+ Aspiration Catheter System | Wallaby Medical | NRY | Class II | 2024-10-01 |
| K242276 | CrossFAST Integrated Microcatheter Guide Extension System (CFM55) | Vantis Vascular, Inc. | DQY | Class II | 2024-09-30 |
| DEN240017 | ShortCut | Pi-Cardia, Ltd. | SCZ | Class II | 2024-09-27 |
| K242557 | ClotTriever XL Catheter (41-102) | Inari Medical, Inc. | QEW | Class II | 2024-09-27 |
| K233446 | AMC Health CareConsole | Amc Health | MWI | Class II | 2024-09-27 |
| K242213 | Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral Intravascular Lithotripsy (IVL) Catheter | Shockwave Medical, Inc. | PPN | Class II | 2024-09-27 |
| K241101 | BioButton System | Biointellisense, Inc. | DRG | Class II | 2024-09-26 |
| K241414 | CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C); CrossWise RF Adapter Cable (Model CW-1002) | Circa Scientific, Inc. | DXF | Class II | 2024-09-26 |
| K242075 | Indigo® Aspiration System Lightning Bolt Aspiration Tubing | Penumbra, Inc. | QEW | Class II | 2024-09-25 |
| K240236 | Happy Ring Health Monitoring System | Happy Health, Inc. | MWI | Class II | 2024-09-24 |
| K240013 | EchoGo Heart Failure (2.0) | Ultromics Limited | QUO | Class II | 2024-09-23 |
| K232670 | HiCardi+ H100 | MEZOO Co., Ltd. | DSH | Class II | 2024-09-20 |
| K242504 | Millipede 088 Access Catheter; Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set | Perfuze, Ltd. | NRY | Class II | 2024-09-20 |
| K240901 | Stethophone | Sparrow Acoustics, Inc. | DQD | Class II | 2024-09-19 |
| K241784 | Arrow® Nitinol Wire | Teleflex Medical | DQX | Class II | 2024-09-18 |
| K241230 | Super Sheath Introducer Sheath S-3N5/1005 S-3N7/1006 S-3W5/1007 S-3W7/1008 | Togo Medikit Co., Ltd. | DYB | Class II | 2024-09-17 |
| K241156 | Medline ReNewal Reprocessed St. Jude Medical Response Electrophysiology Catheter, Supreme Electrophysiology Catheter (401150, 401206, 401207, 401210, 401211, 401212, 401222, 401223, 401226, 401227, 401228, 401260, 401261, 401271, 401305, 401306, 401309, 401310, 401311, 401312, 401317, 401353, 401357, 401381, 401392, 401399, 401400, 401425, 401430, 401433, 401434, 401435, 401436, 401438, 401441, 401442, 401443, 401444, 401445, 401448, 401449, 401450, 401451, 401453, 401466, 401468, 401 | Surgical Instrument Service and Savings, Inc. | NLH | Class II | 2024-09-14 |
| K240087 | RT Carbon ECG Leads | Ivy Biomedical Systems, Inc. | DSA | Class II | 2024-09-13 |
| K231982 | Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2 | Qura S.R.L | DTZ | Class II | 2024-09-12 |
| K240787 | Selectra 3D Lead Delivery System (443624-443629, 451789-451791); Selectra Slitter Tool (383119); Selectra Accessory Kit (375518) | Biotronik, Inc. | DQY | Class II | 2024-09-12 |
| K240880 | VitalFlow Set with Balance Biosurface | Medtronic, Inc. | QJZ | Class II | 2024-09-12 |
| K241362 | Pounce XL Thrombectomy System (PTS-1011-7F135) | Surmodics,Inc. | QEW | Class II | 2024-09-11 |
| K234064 | Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for Siemens Systems) (10135936); Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for GE Systems) (10135910) | Surgical Instrument Service and Savings, Inc. | OWQ | Class II | 2024-09-10 |
| K242612 | Option ELITE Vena Cava Filter System (352506070E 352506100E) | Argon Medical Devices, Inc. | DTK | Class II | 2024-09-10 |
| K240600 | SafeCross Vascular Introducer System (4001) | East End Medical I, LLC | DYB | Class II | 2024-09-06 |
| K233900 | Nordica PV Cryo Mapping Catheter | Synaptic Medical Corporation | DRF | Class II | 2024-09-06 |
| K242319 | Indigo® Aspiration System Aspiration Catheter 6X | Penumbra, Inc. | QEW | Class II | 2024-09-03 |
| K241611 | ShapeIT (SI014135) | Imds Operations B.V. | DQY | Class II | 2024-09-03 |
| K241393 | ODI-Tech | Odi Medical AS | MUD | Class II | 2024-08-30 |
| K241583 | VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-CP-01, VC-CH-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-SP-01, VC-CH-01) | Remington Medical, Inc. | DPW | Class II | 2024-08-30 |
| K241227 | RHYTHMIA HDx Mapping System | Boston Scientific Corporation | DQK | Class II | 2024-08-29 |
| K233827 | OxiWear | Oxiwear, Inc. | DQA | Class II | 2024-08-28 |
19,212 clearances in the Cardiovascular panel. Data: openFDA.