Review Panel
Cardiovascular FDA 510(k) Clearances & Devices
- Cleared Devices
- 19,212
- Product Codes (page)
- 48
- Latest Decision
- 2024-01-31
Clearances · page 11 of 193
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K214115 | MightySat -OTC | Masimo Corporation | OLK | Class II | 2024-01-31 |
| K240004 | CardioCurve Steerable Sheath Small Curl, 40cm (CC-1040S ); CardioCurve Steerable Sheath Medium Curl, 40cm (CC-1040M ); CardioCurve Steerable Sheath Large Curl, 40cm (CC-1040L ); CardioCurve Steerable Sheath Small Curl, 61cm (CC-1061S); CardioCurve Steerable Sheath Medium Curl, 61cm (CC-1061M ); CardioCurve Steerable Sheath Large Curl, 61cm (CC-1061L); CardioCurve Steerable Sheath Small Curl, 71cm (CC-1071S ); CardioCurve Steerable Sheath Medium Curl, 71cm (CC-1071M ); CardioCurve Steer | Circa Scientific, Inc. | DYB | Class II | 2024-01-31 |
| K231303 | Arm-type Fully Automatic Digital Blood Pressure Monitor | Joytech Healthcare Co. , Ltd. | DXN | Class II | 2024-01-26 |
| K234118 | CentriMag Acute Circulatory Support System | ABBOTT MEDICAL | QNR | Class II | 2024-01-26 |
| K231218 | Distal Access Catheter | Accumedical Beijing , Ltd. | QJP | Class II | 2024-01-19 |
| K233736 | LifeSPARC System | Cardiacassist, Inc. | QNR | Class II | 2024-01-19 |
| K232679 | Cleaner Pro Thrombectomy System; Cleaner Pro Aspiration Catheter with Handpiece; Cleaner Pro Aspiration Canister | Argon Medical Devices, Inc. | QEW | Class II | 2024-01-19 |
| K232577 | Radial Compression Device | Ningbo Dizegens Medical Science Co.,Ltd | DXC | Class II | 2024-01-18 |
| K233680 | Celect Platinum Vena Cava Filter Set for Femoral Vein Approach (IGTCFS-65-1-FEM-CELECT-PT); Celect Platinum Vena Cava Filter Set for Jugular Vein Approach (IGTCFS-65-1-JUG-CELECT-PT); Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach (IGTCFS-65-1-UNI-CELECT-PT); Günther Tulip Vena Cava Filter Set for Femoral Vein Approach (IGTCFS-65-1-FEM-TULIP); Günther Tulip Vena Cava Filter Set for Jugular Vein Approach (IGTCFS-65-1-JUG-TULIP); Günther Tulip Vena Cava Filter | William Cook Europe Aps | DTK | Class II | 2024-01-18 |
| K233783 | exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular Grafts | Peca Labs, Inc. | DSY | Class II | 2024-01-17 |
| K233988 | Cerenovus Large Bore Catheter; Cerenovus Aspiration Tubing Set | Cerenovus, Inc. | NRY | Class II | 2024-01-17 |
| K233216 | CLEWICU System | Clew Medical , Ltd. | QNL | Class II | 2024-01-13 |
| K232312 | GORE® PROPATEN® Vascular Graft | W. L. Gore & Associates, Inc. | DSY | Class II | 2024-01-09 |
| K231608 | Teleport XT Microcatheter | OrbusNeich Medical (Shenzhen) Co., Ltd. | DQY | Class II | 2024-01-07 |
| K232721 | Lifetech Cardio Temporary Pacemaker | Shenzhen Lifetech Cardio Medical Electronics Co., Ltd. | DTE | Class II | 2024-01-07 |
| K230996 | Pursuant Health Kiosk (G1.D5) | Pursuant Health | DXN | Class II | 2024-01-04 |
| K230277 | Pulse Oximeter(Model OHT60,OXH78) | Cofoe Medical Technology Co., Ltd. | DQA | Class II | 2024-01-04 |
| K223228 | Dayspring | Koya Medical, Inc. | JOW | Class II | 2024-01-04 |
| K233858 | TriSalus TriGuideTM Guiding Catheter | Trisalus Life Sciences | DQY | Class II | 2023-12-27 |
| K233205 | Distal Access Catheter | Shanghai Heartcare Medical Technology Co., Ltd. | QJP | Class II | 2023-12-22 |
| K231086 | CPM System | Analog Devices, Inc. | MWI | Class II | 2023-12-22 |
| K232300 | ElastiMed SACS | Elastimed , Ltd. | JOW | Class II | 2023-12-22 |
| K233813 | Bearing nsPVA Express | Merit Medical Systems, Inc. | NAJ | Class II | 2023-12-21 |
| K233276 | Reusable Blood Pressure Cuff | Suzhou Minhua Medical Apparatus Supplies Co., Ltd. | DXQ | Class II | 2023-12-21 |
| K231531 | Pediarity | Hinlab, Inc. | DQA | Class II | 2023-12-21 |
| K231402 | HP PTA Balloon Dilatation Catheter | Kossel Medtech (Suzhou) Co., Ltd. | LIT | Class II | 2023-12-20 |
| K232048 | Cogent Hemodynamic Monitoring System; Cogent HMS | Icu Medical | DXG | Class II | 2023-12-20 |
| K233130 | Blood Pressure Monitor | Guangdong Transtek Medical Electronics Co., Ltd. | DXN | Class II | 2023-12-20 |
| K231227 | SureFlex HD Steerable Sheath, VersaCross HD Steerable Sheath | Baylis Medical Company, Inc. | DYB | Class II | 2023-12-20 |
| K232458 | JETiHydrodynamic Thrombectomy System | ABBOTT MEDICAL | QEZ | Class II | 2023-12-19 |
| K231671 | IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866470), IntelliVue 4-Slot Module Rack FMX-4 (866468) | Philips Medizin Systeme Boeblingen GmbH | MHX | Class II | 2023-12-19 |
| K233551 | GORE® ACUSEAL Vascular Graft | W. L. Gore & Associates, Inc. | DSY | Class II | 2023-12-19 |
| K233815 | ClotTriever Sheath | Inari Medical, Inc. | QEW | Class II | 2023-12-18 |
| K233691 | FlexCath Cross Transseptal Solution | Acutus Medical, Inc. | DYB | Class II | 2023-12-17 |
| K231160 | Cardio Q50, Cardio Q70 | Bionet Co., Ltd. | DPS | Class II | 2023-12-15 |
| K233668 | Auryon Atherectomy Catheter 1.5 mm XL, Hydrophilic Coating (EXM-4010-H000), Auryon Atherectomy Catheter 0.9 mm XL, Hydrophilic Coating (EXM-4011-H000), Auryon Atherectomy Catheter 1.5 mm XL (EXM -4010-0000), Auryon Atherectomy Catheter 0.9 mm XL (EXM-4011-0000) | Eximo Medical, Ltd. | MCW | Class II | 2023-12-15 |
| K231478 | Digital Blood Pressure Monitor (Model: YB-800) | Wenzhou Yosun Medical Technology Co.,Ltd | DXN | Class II | 2023-12-15 |
| K223721 | Masimo Stork | Masimo Corporation | DQA | Class II | 2023-12-15 |
| K232130 | Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter | Surgical Instrument Services and Savings, Inc. | OWQ | Class II | 2023-12-15 |
| K233647 | VersaCross Connect Transseptal Dilator | Baylis Medical Company, Inc. | DRE | Class II | 2023-12-14 |
| K233648 | Millipede 088 Access Catheter | Perfuze, Ltd. | QJP | Class II | 2023-12-14 |
| K231801 | MedHealth DVT compression Devices MHH900S/MHH900E | Medhealth Medical Limited | JOW | Class II | 2023-12-14 |
| K231870 | CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System | Ge Medical Systems Information Technologies, Inc. | DQK | Class II | 2023-12-13 |
| K233646 | Intri24 Introducer Sheath (52-101) | Inari Medical, Inc. | DYB | Class II | 2023-12-12 |
| K232815 | Wrist Blood Pressure Monitor | Zhuhai Yueja Medical Device Technology Co., Ltd. | DXN | Class II | 2023-12-11 |
| K233248 | FARADRIVE Steerable Sheath | Boston Scientific Corporation | DRA | Class II | 2023-12-11 |
| K232053 | SimpleSense-BP, SimpleSense-BP Software Application | Nanowear, Inc. | DXN | Class II | 2023-12-08 |
| K233432 | 10F Sheath and Dilator Set | Argon Medical Devices, Inc. | DYB | Class II | 2023-12-08 |
| K231206 | DLP Silicone Coronary Artery Ostial Cannulae | Medtronic, Inc. | DWF | Class II | 2023-12-07 |
| K233562 | LINQ II Insertable Cardiac Monitor | Medtronic, Inc. | MXD | Class II | 2023-12-06 |
| K233521 | QT ECG (QTERD100) | QT Medical, Inc. | DXH | Class II | 2023-12-06 |
| K232814 | Electronic Blood Pressure Monitor | Zhuhai Yueja Medical Device Technology Co., Ltd. | DXN | Class II | 2023-12-05 |
| K223170 | Electronic Blood Pressure Monitor, model: HTD6602US | Hetaida Technology Co., Ltd. | DXN | Class II | 2023-12-05 |
| K233397 | Cosine-10TM Diagnostic Catheter | Medtronic, Inc. | DRF | Class II | 2023-12-02 |
| K231179 | Slinky Catheter | Anoxia Medical, Inc. | QJP | Class II | 2023-12-01 |
| K231211 | Medline ComfortTemp Patient Warming System | Medline Industries, LP | DWJ | Class II | 2023-12-01 |
| K231393 | Radical the Dude 7F Guide Catheter | Maduro Medical, Inc. | QJP | Class II | 2023-11-30 |
| K233503 | 14F iSLEEVE Introducer Set | Boston Scientific Corporation | DYB | Class II | 2023-11-30 |
| K230587 | Wrist Pulse Oximeter | Beijing Choice Electronic Technology Co., Ltd. | DQA | Class II | 2023-11-30 |
| K231821 | XO Cath Microcatheter (E20-090-S, E20-110-S, E20-130-S, E20-150-S, E20-175-S, E20-220-S, E20-090-B, E20-110-B, E20-130-B, E20-150-B, E20-175-B, E20-220-B, E26-090-S, E26-110-S, E26-130-S, E26-150-S, E26-175-S, E26-220-S, E26-090-B, E26-110-B, E26-130-B, E26-150-B, E26-175-B, E26-220-B,) | Transit Scientific, LLC | KRA | Class II | 2023-11-29 |
| K230726 | CEREGLIDE 92 Intermediate Catheter | Cerenovus, Inc. | QJP | Class II | 2023-11-29 |
| K232772 | Blood Pressure Cuff (1201D1,12L2D1,1202D1,12L3D1,1203D1,1204D1,1205D1,1206D1,1207D1-1#,1207D1-2#,1207D1-3#,1207D1-4#,1207D1-5#,1201B1,12L2B1,1202B1,12L3B1,1203B1,1204B1,1205B1,1206B1,1207B1-1#,1207B1-2#,,1207B1-3#,1207B1-4#,1207B1-5#,1201W2,12L2W2,1202W2,12L3W2,1203W2,1204W2,1205W2,1206W2 and 1207W2) | Shenzhen Plinma Technology Co. , Ltd. | DXQ | Class II | 2023-11-29 |
| K231250 | Digital Blood Pressure Monitor | Guangdong Genial Technology Co., Ltd. | DXN | Class II | 2023-11-28 |
| K232713 | Blood Pressure Monitor | Guangdong Transtek Medical Electronics Co., Ltd. | DXN | Class II | 2023-11-28 |
| K231104 | ABPMpro | Somnomedics GmbH | DSH | Class II | 2023-11-27 |
| K233160 | NeuTrace EP Mapping System v.2.1 | Anumana, Inc. | DQK | Class II | 2023-11-25 |
| K231245 | Digital Blood Pressure Monitor (Arm Type) | Guangdong Genial Technology Co., Ltd. | DXN | Class II | 2023-11-22 |
| K232621 | Blood pressure monitor | Guangdong Transtek Medical Electronics Co., Ltd. | DXN | Class II | 2023-11-22 |
| K230604 | IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030) | Philips Medizin Systeme Boeblingen GmbH | MHX | Class II | 2023-11-22 |
| K233110 | Carnation Ambulatory Monitor | Bardy Diagnostics, Inc. | DSH | Class II | 2023-11-22 |
| K222712 | Fogg System Patient Monitoring Cables | Fogg System Company, Inc. | DSA | Class II | 2023-11-22 |
| K232573 | INFINITI Ambi Angiographic Catheter | Cordis US Corp | DQO | Class II | 2023-11-21 |
| K232388 | High Pressure Tubing | Ningbo Dizegens Medical Science Co.,Ltd | DXT | Class II | 2023-11-21 |
| K230834 | CARDIPIA ECG / Model: CARDIPIA400H, CARDIPIA800H | Trismed Co., Ltd. | DPS | Class II | 2023-11-21 |
| K232512 | Masimo W1 | Masimo Corporation | DPS | Class II | 2023-11-17 |
| K230612 | Edwards Algorithm for Measurement of Blood Hemoglobin | Edwards Lifesciences, LLC | MUD | Class II | 2023-11-17 |
| K232974 | EKGenius Smart System | Ekgenius, LLC | DPS | Class II | 2023-11-17 |
| K231600 | SENDERO Microcatheter | Okami Medical, Inc. | DQY | Class II | 2023-11-17 |
| K231652 | D100 KIDS; D101 KIDS | Sorin Group Italia S.R.L. | DTZ | Class II | 2023-11-16 |
| K231554 | UniPearls® Embolic Microspheres | Suzhou Haowei Medical Technology Co., Ltd. | KRD | Class II | 2023-11-14 |
| K231150 | Cardio P1 | Bionet Co., Ltd. | DPS | Class II | 2023-11-09 |
| K231773 | Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT75-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT75-C2U, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT200-C2U, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT160-C1U | Qura S.R.L | DTZ | Class II | 2023-11-08 |
| DEN220091 | Dream Sock | Owlet Babycare, Inc. | QYU | Class II | 2023-11-08 |
| K231586 | Endophys Blood Pressure Monitor model BPM-30 | Endophys Technologies, LLC | DSK | Class II | 2023-11-03 |
| K231182 | Thermogard HQ Temperature Management System, Thermogard XP® Temperature Management System | Zoll Circulation, Inc. | NZE | Class II | 2023-11-03 |
| K232730 | Aventus Thrombectomy System | Inquis Medical | QEW | Class II | 2023-11-01 |
| K231414 | CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009) | Chalice Medical , Ltd. | DTZ | Class II | 2023-11-01 |
| K232321 | FlexCath Contour Steerable Sheath | Medtronic, Inc. | DRA | Class II | 2023-10-31 |
| K232294 | HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta Advanced Monitor (Smart Recovery); HemoSphere Alta Advanced Monitor (Cardiac); HemoSphere Alta Advanced Monitor (All-on-One) | Edwards Lifesciences, LLC | DQK | Class II | 2023-10-31 |
| K231362 | OCS Heart Leukocyte Depleting Filter | TransMedics, Inc. | DTM | Class II | 2023-10-31 |
| K231629 | 091 Balloon Guide Catheter | Eosolutions, Corp. | DQY | Class II | 2023-10-31 |
| K231243 | Finger Clip Pulse Oximeter | Guangdong Genial Technology Co., Ltd. | DQA | Class II | 2023-10-31 |
| K233320 | LINQ II Insertable Cardiac Monitor (LNQ22) | Medtronic, Inc. | MXD | Class II | 2023-10-31 |
| K230457 | Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal | Empatica S.r.l. | MWI | Class II | 2023-10-30 |
| K230418 | Mighty Wire Guide Wire | Merit Medical Systems, Inc. | DQX | Class II | 2023-10-28 |
| K233270 | AcuNav Crystal Ultrasound Catheter | Siemens Medical Solutions USA, Inc. | OBJ | Class II | 2023-10-28 |
| K231310 | Electronic Blood Pressure Monitor | Shenzhen Jumper Medical Equipment Co., Ltd. | DXN | Class II | 2023-10-27 |
| K233207 | Polaris X Unidirectional Steerable Diagnostic Catheter | Boston Scientific Corporation | DRF | Class II | 2023-10-27 |
| K233091 | Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors (CP37V-VT); Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors (CP22V-VT) | Qura S.R.L | KFM | Class II | 2023-10-26 |
| K230842 | SignalHF (IM008) | Implicity, Inc. | QNL | Class II | 2023-10-25 |
19,212 clearances in the Cardiovascular panel. Data: openFDA.