meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
50
Latest Decision
2001-02-22

Clearances · page 100 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K002079 MULTI-FUNCTION DEFIBRILLATION ELECTRODE Medicotest A/S MKJ Class III 2001-02-22
K002758 AGILENT COMPONENT MONITORING SYSTEM, AGILENT CARDIAC OUTPUT MODULE, AGILENT INVASIVE PRESSURE MODULE, MODEL M1175A/76A Agilent Technologies Deutschland GmbH DSI Class II 2001-02-22
K001852 PERIPHERAL ARTERIAL TONOMETER-PAT 1000RD DEVICE Itamar Medical (C.M.) 1997 , Ltd. DQK Class II 2001-02-21
K002054 X-SEPT TRANSSEPTAL SHEATH AND TRANSITION CATHETER, MODEL MV-03-09-90, MV-03-10-90, MV-03-11-90, MV-03-09-120, MV-03-10-1 Appriva Medical, Inc. DYB Class II 2001-02-16
K003667 REVEAL PLUS INSERTABLE LOOP RECORDER Medtronic Vascular MXC Class II 2001-02-14
K010342 M2376A DEVICELINK SYSTEM, MODEL M2376A Agilent Technologies, Inc. MWI Class II 2001-02-14
K003782 CONSTELLATION CATHETER, MODEL 8031 Boston Scientific Corp MTD Class II 2001-02-14
K010169 BARD UTRAVERSE SMALL VESSEL PTA BALLOON DILATATION CATHETER C.R. Bard, Inc. DQY Class II 2001-02-13
K010004 FLOWRIDER FLOW DIRECTED MICRO CATHETER, MODEL 105-5065 Micro Therapeutics, Inc. KRA Class II 2001-02-13
K010190 WRISTWATCH BLOOD PRESSURE MONITOR, MODEL A43 Rossmax Internationl , Ltd. DXN Class II 2001-02-08
K002068 ORG-9200A Nihon Kohden America, Inc. DSI Class II 2001-02-08
K003940 2010 PLUS HOLTER FOR WINDOWS Agilent Technologies MLO Class II 2001-02-08
K003535 STYLET KIT, MODELS 6254,6282,6293 Medtronic Vascular DRB Class II 2001-02-08
K000776 MEDTRONIC DLP ARTERIAL CANNULAE WITH 3D TIP Medtronic Cardiac Surgical Products DWF Class II 2001-02-07
K003604 ADAPTERS WITH X-COATING Terumo Cardiovascular Systems Corp. DTL Class II 2001-02-07
K003495 ANCURE LLIAC BALLOON CATHETER Guidant Cardiac and Vascular Surgery DQY Class II 2001-02-07
K002280 PAD PRO PEDIATRIC ELECTRODE, MODEL PAD PRO 2602 Medical Devices, Inc. MKJ Class III 2001-02-05
K990284 BAYLIS MEDICAL RF SEPTOSTOMY GENERATOR, NYKANEN RF SEPTOSTOMY CATHETER, BAYLIS MEDICAL CONNECTOR CABLE Baylis Medical Co., Inc. DXF Class II 2001-02-01
K010048 M2376A DEVICELINK SYSTEM Agilent Technologies, Inc. MWI Class II 2001-02-01
K010099 ZYNERGY Z3K BALLOON GUIDED PACING AND MONITORING CATHETER Zcv ,Inc. LDF Class II 2001-02-01
K002822 VERTEX SYSTEM Medical Positioning, Inc. DPS Class II 2001-01-31
K002445 LIFEPAK 12DEFIBERLLATOR/MONITOR SERIES Medtronic Physio-Control Corp. MKJ Class III 2001-01-31
K003394 APPALEAD GW+03XXXXXXR SERIES Nipro Medical Corp. DQX Class II 2001-01-30
K002791 NONINVASIVE BLOOD PRESSURE MEASUREMENT SYSTEM Unix Electronic Co. , Ltd. DXN Class II 2001-01-29
K002273 STOCKERT A272 SERIES PEDIATRIC AORTIC CANNULAE Stoeckert Instrumente DWF Class II 2001-01-29
K001543 BPC-3000 PERSONAL BLOOD PRESSURE COMMUNICATOR, MODEL 52520 Welch Allyn, Inc. DXN Class II 2001-01-29
K003467 CHASE CARDIOVASCULAR PATCH Chase Medical, Inc. DXZ Class II 2001-01-29
K001985 INTRODEUCE DOUBLE LUMEN INTRODUCER Cook, Inc. DYB Class II 2001-01-25
K003392 CARDIO MONITOR CENTER VISION; MODEL S-CV7-00 Shl Telemedicine International , Ltd. DPS Class II 2001-01-25
K004007 DR180+OXY North East Monitoring, Inc. DSH Class II 2001-01-25
K003576 Q-TEL RMS (REHABILITATION MANAGEMENT SYSTEM), MODEL 000503 Quinton, Inc. DSI Class II 2001-01-25
K002007 SULZER VASCUTEK GELSOFT ERS VASCULAR PROSTHESIS Sulzer Carbomedics, Inc. DSY Class II 2001-01-25
K001961 STOCKERT A242 AND A252 SERIES ARTERIAL FEMORAL CANNULAE Stoeckert Instrumente DWF Class II 2001-01-25
K002061 A&D MEDICAL TM-2550/TM-2551/TM-2560 VITAL SENSOR MONITOR A&D Engineering, Inc. DRT Class II 2001-01-19
K003964 TRAPEASE PERMANENT VENA FILTER AND INTRODUCTION KIT, MODELS 466-P306A AND 466-P306B Cordis Corp. DTK Class II 2001-01-19
K003368 ACROTHERM Aquarius Medical Corp. DWJ Class II 2001-01-19
K003454 A1-CS-SB Y-ADAPTER, MODEL 124 871 Biotronik, Inc. DTD Class II 2001-01-18
K003938 TRAK BACK II Jomed, Inc. DQO Class II 2001-01-18
K003492 ANALYTIC SPECTRAL METHOD OF ALTERNANS PROCESSING; CH 2000 CARDIAC DIAGNOSTIC SYSTEM; HEARTWAVE ALTERNANS PROCESSING SYS Cambridge Heart, Inc. DQK Class II 2001-01-18
K003901 ANGIODYNAMICS SOFT-VU SIZING ANGIOGRAPHIC CATHETER AngioDynamics, Inc. DQO Class II 2001-01-17
K003284 PHLEBOPUMP, MODEL 1000 Prevent Products, Inc. JOW Class II 2001-01-17
K001775 ZOE MEDICAL NIGHTINGALE MONITORING SYSTEM Zoe Medical, Inc. DRT Class II 2001-01-12
K001577 OUTBACK CATHETER Lumend, Inc. DQY Class II 2001-01-11
K003485 CARE PROVIDER STATION ADDITION OF WEIGHT SCALE Cybercare Technologies, Inc. DQD Class II 2001-01-11
K002067 RADIANALYZER, MODEL 12710 Radi Medical Systems AB DSK Class II 2001-01-11
K003902 MULTITRACK ANGIOGRAPHIC CATHETER NuMED, Inc. DQO Class II 2001-01-11
K003972 NUMED GHOST II PTA CATHETERS NuMED, Inc. LIT Class II 2001-01-11
K001802 VENODYNE DVT ADVANTAGE MODEL 610 Microtek Medical, Inc. JOW Class II 2001-01-09
K003072 PACING LEADS, GUIDE WIRES, AND VARIOUS ACCESSORIES Biotronik, Inc. DTB Class III 2001-01-09
K002603 ZYNERGY BALLOONPACE BALLOON GUIDED PACING AND MONITORING CATHETER Zcv ,Inc. LDF Class II 2001-01-08
K990800 INTERGARD KNITTED ULTRA THIN AND INTERGARD KNITTED COLLAGEN COATED AND HEPARIN BONDED VASCULAR PROTHESIS Intervascular, Inc. DSY Class II 2001-01-08
K003925 PROWLER INFUSION CATHETERS WITH PRE-SHAPED TIPS Cordis Neurovascular, Inc. KRA Class II 2001-01-08
K001896 KENZ ECG 108 SINGLE CHANNEL DIGITAL ELECTROCARDIOGRAPHS; KENZ ECG 110 SINGLE CHANNEL DIGITAL ELECTROCARDIOGRAPHS WITH EC Suzuken Co., Ltd. DPS Class II 2001-01-08
K002915 FLEXIBLE OCCLUSION SYSTEM Applied Medical DXC Class II 2001-01-08
K003763 2010 PLUS HOLTER FOR WINDOWS Agilent Technologies MLO Class II 2001-01-05
K003729 ULTIMUM EV HEMOSTASIS INTRODUCER (14F), ULTIMUM EV HEMOSTASIS INTRODUCER (16F), ULTIMUM EV HEMOSTASIS INTRODUCER (18F), St Jude Medical DYB Class II 2001-01-03
K003415 ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE Wang & Li, Inc. DXQ Class II 2001-01-03
K002197 CARTOUCH Cardionics, Inc. DPS Class II 2000-12-27
K001785 SURGISIS PERIPHERAL VASCULAR PATCH Cook Biotech, Inc. DXZ Class II 2000-12-27
K003643 NUMED Z-MED PTV CATHERERS NuMED, Inc. DQY Class II 2000-12-27
K002976 RESPONSE ELECTROPHYSIOLOGY CATHETER, SUPREME ELECTROPHYSIOLOGY CATHETER, MODEL 401XXX AND 401XXX St Jude Medical DRF Class II 2000-12-22
K002955 EMPIRE N BLOOD PRESSURE MANOMETERS Rudolf Riester GmbH & Co. KG DXQ Class II 2000-12-21
K003248 SIEMENS MEDICAL INFORMATION BUS (MIB) PROTOCOL CONVERTER Siemens Medical Solutions USA, Inc. MHX Class II 2000-12-21
K002954 RI-SAN/RI-SANA BLOOD PRESSURE MANOMETERS Rudolf Riester GmbH & Co. KG DXQ Class II 2000-12-21
K003371 PUMP TUBING WITH X-COATING Terumo Corp. DWF Class II 2000-12-21
K003598 DATASCOPE PROFILE 8FR. ALT B IAB, 34CC, DATASCOPE PROFILE 8FR. ALT B IAB, 40CC, MODEL 0684-000319, 0684-00-0320 Datascope Corp. DSP Class II 2000-12-21
K003724 CBMYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM WITH CARMEDA BIOACTIVE SURFACE, MODELS CB41 AND CB41-B Medtronic Vascular DTR Class II 2000-12-21
K991093 MSD EMBOLECTOMY BASKET Metamorphic Surgical Devices, LLC QEW Class II 2000-12-21
K001634 CARDIOSENTRY EVENT MONITOR, MODEL 8470-01 Tz Medical, Inc. DXH Class II 2000-12-21
K003243 SIEMENS INFINITY MODULAR MONITORS MODEL SC 8000; SC 7000; SC 9000XL Siemens Medical Solutions USA, Inc. MHX Class II 2000-12-21
K003246 SIEMENS MULTI VIEW WORKSTATION WITH VENT VIEWER OPTION Siemens Medical Solutions USA, Inc. DSI Class II 2000-12-21
K003621 ST/AR ST AND ARRHYTHMIA SOFTWARE, MODEL RELEASE D.0 Agilent Technologies, Inc. MHX Class II 2000-12-20
K003118 Z2 BALLOON GUIDED PACING & PRESSURE MONITORING CATHETER, MODEL Z2-7-02-1-10-0 Zcv ,Inc. DYG Class II 2000-12-20
K003565 HEARTSTREAM FR2 AED, MODEL M3860A,M3861A Agilent Technologies, Inc. MKJ Class III 2000-12-20
K002984 EHC400 DESKTOP PATIENT STATION; EHC600 CARE PROVIDER STATION Cybercare Technologies, Inc. DQD Class II 2000-12-18
K001927 VECTRA (TM) VASCULAR ACCESS GRAFT-5MM DIAMETER,6MM DIAMETER AND VECTRA (TM) VASCULAR ACCESS GRAFT FOR REVISION-5MM DIAME Thoratec Laboratories Corp. DSY Class II 2000-12-18
K003622 M2376A DEVICELINK SYSTEM, MODEL M2376A Agilent Technologies, Inc. MWI Class II 2000-12-18
K003711 AMBULATORY BLOOD PRESSURE MONITORING SYSTEM, MODEL SE-25M/25P Sein Electronics Co., Ltd. DXN Class II 2000-12-15
K003228 K-DEFIB/PACE MULTIFUCTION PEDIATRIC ELECTRODE, MODEL KDP-70A Katecho, Inc. MKJ Class III 2000-12-14
K003520 NEXAN SYSTEM, MODEL NX-300 Nexan, Ltd. MWJ Class II 2000-12-13
K002481 ZYNERGY FEATHERPACE TRANSVENOUS BIPOLAR CATHETER, MODEL 04-X-02-3-10-3 Zcv ,Inc. LDF Class II 2000-12-07
K003452 POLARIS X CATHETERS, MODEL 7000D,7001D,7003D,7004D,7005D,7006D Ep Technologies, Inc. DRF Class II 2000-12-07
K001621 DARDIK CAROTID SHUNT Vascutech, Inc. MJN Class II 2000-12-06
K003483 MODIFIED HYDROPHILIC COATED GUIDEWIRE (STAINLESS STEEL CORE) Lake Region Mfg., Inc. DQX Class II 2000-12-06
K003469 EECP THERAPY SYSTEM, MODEL TS3 Vasomedical, Inc. DRN Class II 2000-12-06
K002232 AEDEFIBRILLATOR Medical Research Laboratories, Inc. MKJ Class III 2000-12-06
K002105 SIEMENS INFINITY SC 6002XL ENHANCED WITH ST SEGMENT ANALYSIS Siemens Medical Solutions USA, Inc. MLD Class II 2000-12-05
K003276 TYSHAK MINI PEDIATRIC PTV CATHETER, MODEL 107 NuMED, Inc. LIT Class II 2000-12-01
K003398 WIRECLIP TORQUER Boston Scientific Corporation Northwest Technology DQX Class II 2000-12-01
K002493 DIDECO MICRO 40 PH.I.S.I.O (PHOSPHORYLCHOLINE INSERT SURFACE IN OXGENATION) NEWBORN/INFANT ARTERIAL FILTER Cobe Cardiovascular, Inc. DTM Class II 2000-11-30
K002766 NICOLET VASOGUARD Nicolet Biomedical JOP Class II 2000-11-30
K000004 ALLIANCE LEFT HEART DELIVERY SYSTEM INTRODUCER, MODEL #407509 Daig Corp. DYB Class II 2000-11-29
K002787 MODEL 120, OXYSOFT, INFRARED DATA CONVERTER, MODEL 120 Palco Labs, Inc. DQA Class II 2000-11-29
K002781 MEDICAL CABLES PATIENT MONITORING CABLES FOR ECG, EEG, SPO2, AND BLOOD PRESSURE MONITORS Medical Cables, Inc. DSA Class II 2000-11-29
K000404 PC ECG 1200 Norav Medical , Ltd. MWI Class II 2000-11-22
K001520 ALPHA OMEGA DUAL COOLER-HEATER Alpha Omega, Inc. DWC Class II 2000-11-22
K002047 DRG PURETONE STETHOSCOPE WITH DRG ANTIMICROBIAL, STETHOSCOPE DIAPHRAGM, MODEL PT2B27(CARDIOLOGY), PT3B27(CLASSIC), PT5B2 Doctor'S Research Group, Inc. DQD Class II 2000-11-22
K003444 MODEL WS-500 DIGITAL WRIST BLOOD PRESSURE MONITOR Nihon Seimitsu Sokki Co., Ltd. DXN Class II 2000-11-21
K002806 K-DEFIB/PACE, MODEL KDP-60A Katecho, Inc. MKJ Class III 2000-11-21
K002089 ROSETTA-LT/ROSETTA-RX General Devices DRG Class II 2000-11-21

19,212 clearances in the Cardiovascular panel. Data: openFDA.