Review Panel
Cardiovascular FDA 510(k) Clearances & Devices
- Cleared Devices
- 19,212
- Product Codes (page)
- 44
- Latest Decision
- 2016-09-22
Clearances · page 37 of 193
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K162384 | TrailBlazer Angled Support Catheter | Medtronic Vascular, Inc.(Formerly Ev3 Inc.) | DQY | Class II | 2016-09-22 |
| K161879 | Solitaire Platinum Revascularization Device | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | NRY | Class II | 2016-09-21 |
| K162359 | Surefire Guiding Catheter | Surefire Medical, Inc. | DQY | Class II | 2016-09-21 |
| K162338 | Full Automatic (NIBP) Blood Pressure Monitor | Health & Life Co., Ltd. | DXN | Class II | 2016-09-21 |
| K162016 | Affinity NT Oxygenator with Cortiva BioActive Surface | Medtronic, Inc. | DTZ | Class II | 2016-09-21 |
| K161887 | Verrata PLUS Pressure Guide Wire, 185 cm Straight Tip, Verrata PLUS Pressure Guide Wire, 185 cm J-Tip, Verrata PLUS Pressure Guide Wire, 300 cm Straight Tip, Verrata PLUS Pressure Guide Wire, 300 cm J-Tip | Volcano Corporation | DQX | Class II | 2016-09-20 |
| K160919 | Hansen Medical Magellan Robotic Catheter 9Fr | Hansen Medical, Inc. | DRA | Class II | 2016-09-20 |
| K161262 | Super Distal Access (SDA) | Inneuroco, Inc. | DQY | Class II | 2016-09-19 |
| K160862 | AirStrip RPM | Airstrip Technologies, Inc. | MSX | Class II | 2016-09-19 |
| K153654 | Sentry WEB SmartInterp | Carefusion Germany 234 GmbH | DQK | Class II | 2016-09-16 |
| K152946 | TEMPEDY | Seiratherm GmbH | NCX | Class II | 2016-09-15 |
| K162012 | CARESCAPE Central Station V2 | GE Healthcare | DXJ | Class II | 2016-09-15 |
| K153311 | Flexitouch System | Tactile Systems Technology, Inc. (Dba Tactile Medical) | PPS | Class II | 2016-09-14 |
| K161384 | Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector Cable, Lithoplasty Connector Cable | Shockwave Medical, Inc. | PPN | Class II | 2016-09-14 |
| K153771 | TXM Guiding Sheath | Texasmedical Technologies, Inc. | DYB | Class II | 2016-09-13 |
| K161263 | OptoMonitor II | Opsens, Inc. | DXO | Class II | 2016-09-13 |
| K151839 | AMC Health VitalCaregiving System | Amc Health | MWI | Class II | 2016-09-09 |
| K162228 | TorqVue Low Profile Delivery Catheter | Aga Medical Corporation (Wholly Owned by St.Jude Medical Cor | DQY | Class II | 2016-09-09 |
| K161465 | CardioConfirm | Mortara Instrument, Inc. | DQK | Class II | 2016-09-03 |
| K160582 | WiCap | Athena Gtx | DQA | Class II | 2016-09-02 |
| K153707 | Nihon Kohden Vital Sign Telemeter | Nihon Kohden Corporation | MHX | Class II | 2016-09-02 |
| K162184 | Edwards eSheath Introducer Set | Edward Lifesciences | DYB | Class II | 2016-09-02 |
| K160593 | Indy OTW Vascular Retriever | Cook Incorporated | MMX | Class II | 2016-09-02 |
| K161602 | Arctic Sun Temperature Management System | Medivance, Inc. | DWJ | Class II | 2016-09-02 |
| K153494 | HQS Introducer (Model 2064-HQS) | Alseal | DYB | Class II | 2016-08-25 |
| K152659 | V10 | Mediana Co., Ltd. | DXN | Class II | 2016-08-25 |
| K161126 | ASAHI Corsair Pro | Asahi Intecc Co., Ltd. | DQY | Class II | 2016-08-25 |
| K161772 | FFRct | HeartFlow, Inc. | PJA | Class II | 2016-08-24 |
| K161249 | Streamline 6495 Bipolar Temporary Myocardial Pacing Lead | Medtronic | LDF | Class II | 2016-08-19 |
| K161287 | DxTerity, DxTerity TRA, DxTerity Angio-Kit, DxTerity EZ-Pak, DxTerity TRA Angio-Kit, DxTerity TRA EZ-Pak | Medtronic Vascular | DQO | Class II | 2016-08-19 |
| K152091 | Fingertip Pulse Oximeter | Jiangsu Konsung Bio-Medical Science & Technology Co., Ltd. | DQA | Class II | 2016-08-18 |
| K161105 | Reprocessed Compression Garments | Covidien | JOW | Class II | 2016-08-18 |
| K161402 | Bullfrog Micro-Infusion Device | Mercator Medsystems, Inc. | KRA | Class II | 2016-08-18 |
| K152390 | Medke Oximetry Finger Sensor | Shenzhen Medke Technology Co., Ltd. | DQA | Class II | 2016-08-18 |
| K153397 | S-Wire Guidewire System | Concert Medical, LLC | DQX | Class II | 2016-08-18 |
| K161315 | Vein Clamps, Artery Clamps | Aros Surgical Instruments Corporation | DXC | Class II | 2016-08-18 |
| K152089 | Wrist Pulse Oximeter | Jiangsu Konsung Bio-Medical Science & Technology Co., Ltd. | DQA | Class II | 2016-08-17 |
| K161171 | PressureWire X Guidewire | St. Jude Medical, Inc. | DXO | Class II | 2016-08-15 |
| K160840 | ECG100+, ECG200+ | Cardioline S.P.A | DPS | Class II | 2016-08-12 |
| K161336 | VSI StraitSet micro-introducer kit | Vascular Solutions, Inc. | DRE | Class II | 2016-08-11 |
| K160565 | Fully Automatic Electronic Blood Pressure Monitor | Andon Health Co, Ltd. | DXN | Class II | 2016-08-10 |
| K161240 | Rhythm View Workstation (non-streaming) | Abbott Electrophysiology | DQK | Class II | 2016-08-10 |
| K152135 | Quantitative Electrocardiographic Detector (QED 2000) | Acme Portable Machines, Inc. | DPS | Class II | 2016-08-09 |
| K153742 | Apollo Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | LOX | Class II | 2016-08-08 |
| K161985 | Steerable Guide Catheter | Abbott Vascular | DRA | Class II | 2016-08-07 |
| K161245 | EP-TRACER System | Cardio Tek, BV | DQK | Class II | 2016-08-05 |
| K160865 | Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6100C Series: 6100CA, 6100CP, 6100CI, 6100CN), Model 6101C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6101C Series: 6101CA, 6101CP, 6101CI, 6101CN), Model 6102C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6102C Series: 6102CA, 6102CP, 6102CI, 6102CN), Model 8100AA/8100AP Reusable, Finger Clip Pulse Oximeter Sensor, Model 8101AA/8101AP Reusable, Finger Clip Pulse Oximeter Senso | Nonin Medical, Inc. | DQA | Class II | 2016-08-05 |
| K161986 | SIDEKICK and USHER Support Catheters | Bard Peripheral Vascular, Inc. | DQY | Class II | 2016-08-04 |
| K160563 | Fully Automatic Electronic Blood Pressure Monitor | Andon Health Co, Ltd. | DXN | Class II | 2016-08-04 |
| K160685 | Surveyor S4 Mobile Monitor | Mortara Instrument, Inc. | MHX | Class II | 2016-08-04 |
| K161505 | DyeVert NG Contrast Modulation System | Osprey Medical, Inc. | DXT | Class II | 2016-08-03 |
| K160219 | Hilal Embolization MicroCoils | Cook Incorporated | KRD | Class II | 2016-08-03 |
| K160961 | Mozec NC-Rx PTCA Baloon Dilatation Catheter | Meril Life Sciences Private Limited | LOX | Class II | 2016-07-30 |
| K161427 | Pirouette 035 | Arravasc Limited | LIT | Class II | 2016-07-30 |
| K160107 | DiamondTOUCH Inflation Device and Fluid Dispensing Syringe | Merit Medical Systems, Inc. | DXT | Class II | 2016-07-29 |
| K161801 | CrossCath Support Catheter | Cook Incorporated | KRA | Class II | 2016-07-29 |
| K160256 | Polux , Minerva and Atropos PTA Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | LIT | Class II | 2016-07-29 |
| K160747 | Angel Catheter | Bio2 Medical, Inc. | PNS | Class II | 2016-07-28 |
| DEN150029 | Permaseal | Micro Interventional Devices,Inc. | PNQ | Class II | 2016-07-27 |
| K150932 | Sheath Introducer | Bioteque Corp. | DRE | Class II | 2016-07-22 |
| K161218 | Gianturco-Roehm Birds Nest Vena Cava Filter | Cook Incorporated | DTK | Class II | 2016-07-22 |
| K153473 | Braemar Telemetry Patch System | Braemar Manufacturing, LLC | DSI | Class II | 2016-07-22 |
| K152913 | GORE TIPS Set, GORE TIPS Sheath, GORE TIPS Needle | Creganna Medical Aslo Business AS Cregganna Tactx Medical | DYB | Class II | 2016-07-21 |
| K153557 | ABPM 7100, Hypertension Management Software | I.E.M. GmbH | DXN | Class II | 2016-07-19 |
| K161659 | FlexSeal Introducer Sheath with Hydrophilic Coating | Libramedical, Inc. | DYB | Class II | 2016-07-15 |
| K160016 | Steth IO | Stratoscientific, Inc. | DQD | Class II | 2016-07-15 |
| K160704 | myPatch-s | Dms-Service, LLC | DSH | Class II | 2016-07-15 |
| K160848 | Wingman 18 Crossing Catheter | Reflow Medical, Inc. | DQY | Class II | 2016-07-14 |
| K160431 | ActiveCare Home | Medical Compression Systems (Dbn) , Ltd. | JOW | Class II | 2016-07-13 |
| K160448 | ARTLINE | Health Line International Corporation | DQY | Class II | 2016-07-12 |
| K161640 | Penumbra System ACE 68 Reperfusion Catheter | Penumbra, Inc. | NRY | Class II | 2016-07-12 |
| K161333 | TightRail Sub-C Rotating Dilator Sheath | Spectranetics, Inc. | DRE | Class II | 2016-07-08 |
| K160557 | Full Automatic (NIBP) Blood Pressure Monitor | Health & Life Co., Ltd. | DXN | Class II | 2016-07-06 |
| K160956 | LD-Oxi system | Ld Technology, LLC | MWI | Class II | 2016-07-06 |
| K160439 | SunTech CT40 Spot-check Vital Signs Device | Suntech Medical | DXN | Class II | 2016-07-06 |
| K153533 | Tearaway Introducer Sheath, MicroSlide Tearaway Introducer | Galt Medical Corp. | DYB | Class II | 2016-07-05 |
| K161531 | IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2; IntelliVue Patient Monitors MP20, MP30, MP40, MP50, MP60; IntelliVue Patient Monitors MP70, MP80, MP90;IntelliVue Patient Monitors MX400, MX430, MX450, MX500, MX550, MX600;IntelliVue Patient Monitors MX700, MX800 | Philips Medizin Systeme Boeblingen GmbH | MHX | Class II | 2016-07-01 |
| K161523 | INDIGO Aspiration System | Penumbra, Inc. | QEW | Class II | 2016-07-01 |
| K161302 | PC ECG | Edan Instruments, Inc. | DPS | Class II | 2016-07-01 |
| K153739 | MRI Patient Monitor TeslaDUO | Mipm Mammendorfer Institut Fur Physik Und Medizin | MWI | Class II | 2016-06-28 |
| K153033 | Digital Blood Pressure Monitor | Suzhou Sunspiri Co., Ltd. | DXN | Class II | 2016-06-24 |
| K161164 | CareEvent inclusive of the CareEvent Mobile Application accessory | Philips Medical Systems | MSX | Class II | 2016-06-24 |
| K153006 | Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) Catheter | Sterilmed, Inc. | NLH | Class II | 2016-06-23 |
| K160823 | NC Quantum Apex PTCA Dilatation Catheter | Boston Scientific Corporation | LOX | Class II | 2016-06-23 |
| K153682 | Chocolate XD PTCA Balloon Catheter | Trireme Medical, LLC | LOX | Class II | 2016-06-23 |
| K160514 | OptiCross 18, 30 MHz Peripheral Imaging Catheter | Boston Scientific Corporation | OBJ | Class II | 2016-06-22 |
| K152863 | Portable ECG Monitor | Contec Medical Systems Co.,Ltd | DPS | Class II | 2016-06-22 |
| K153106 | ASAHI Fielder XT-A, ASAHI Fielder XT-R | Asahi Intecc Co., Ltd. | DQX | Class II | 2016-06-21 |
| K153225 | Masimo Root Monitoring System and Accessories | Masimo Corporation | MWI | Class II | 2016-06-21 |
| K160598 | REBOA Balloon Catheter | NuMED, Inc. | MJN | Class II | 2016-06-20 |
| K160681 | CenterCross Ultra Catheter | Roxwood Medical, Inc. | DQY | Class II | 2016-06-17 |
| K160645 | PreSep Oligon Oximetry Catheter | Edwards Lifesciences, LLC | DQE | Class II | 2016-06-16 |
| K161346 | NormaTec PCD-T and PCD-B | NormaTec Industries, LP | JOW | Class II | 2016-06-15 |
| K161362 | ASAHI Corsair Armet | Asahi Intecc Co., Ltd. | DQY | Class II | 2016-06-14 |
| K161156 | Full Automatic (NIBP) Blood Pressure Monitor | Health & Life Co., Ltd. | DXN | Class II | 2016-06-14 |
| K161062 | NR Recorder | Norav Medical GmbH | MWJ | Class II | 2016-06-13 |
| K153702 | M3290B Philips IntelliVue Information Center iX | Philips Medical Systems | MHX | Class II | 2016-06-13 |
| K161035 | Medline Singe Patient Use Blood Pressure Cuff | Medline Industries, Inc. | DXQ | Class II | 2016-06-13 |
| K160018 | Arrow Quickflash Arterial Catheterization Device | Arrow International, Inc. (Subsidiary of Teleflex, Inc.) | DQX | Class II | 2016-06-13 |
| K161064 | Penumbra System ACE 68 Reperfusion Catheter | Penumbra, Inc. | NRY | Class II | 2016-06-12 |
19,212 clearances in the Cardiovascular panel. Data: openFDA.