meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
47
Latest Decision
1994-09-21

Clearances · page 123 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K941977 TAYLOR LONG TERM MONITORING ELECTRODE Taylor Industries, Inc. DRX Class II 1994-09-21
K942191 URESIL DILATOR Uresil Corp. DYB Class II 1994-09-21
K944257 LIONHEART 3 MULTI-PARAMETER SIMULATOR Bio-Tek Instruments, Inc. DRT Class II 1994-09-21
K943022 CARDIOMETRICS FLOWIRE DOPPLER GUIDE WIRE Cardio Metrics, Inc. DQX Class II 1994-09-19
K943276 WARMTOUCH PLASTIC WARMING COVER Mallinckrodt Medical DWJ Class II 1994-09-19
K943340 CORDIS STEERABLE GUIDEWIRE Cordis Corp. DQX Class II 1994-09-16
K944107 VIP PLUS PERCUTANEOUS INTRODUCER Medamicus, Inc. DYB Class II 1994-09-14
K940231 INTRA-AORTIC BALLOON FOR OPTIONAL SHEATHLESS INSERTION Datascope Corp. DSP Class II 1994-09-13
K943298 MS CLASSIQUE BALLOON CATHETER Meadox Medicals, Div. Boston Scientific Corp. LIT Class II 1994-09-08
K940842 UNIPOWER RECHARGEABLE BATTERY PACK Unipower Corp. LDD Class II 1994-09-07
K935281 ARBO H87P, H85P, H27P DISPOSABLE MONITORING ELECTRODES Arbo Medical, Inc. DRX Class II 1994-09-06
K941763 ELECTRONIC-AMPLIFIED STETHOSCOPE Hsues' Brothers Medical, Inc. DQD Class II 1994-09-06
K942259 TECHNICUFF Technicuff Corp. DXQ Class II 1994-09-06
K942752 MARQUETTE EAR PROBE SENSOR Marquette Electronics, Inc. DPZ Class II 1994-09-02
K934711 PROPAQ ECG TELEMETRY OPTION Protocol Systems, Inc. DRG Class II 1994-09-01
K933519 INDEX SPO2 SIMULATOR Bio-Tek Instruments, Inc. DQA Class II 1994-09-01
K941710 SCIMED TRANSEND STEERABLE GUIDE WIRE AND ACCESSORIES Scimed Peripheral Interventions DQX Class II 1994-09-01
K942333 SCIMED EN TRE' III PTCA GUIDE WIRE Scimed Life Systems, Inc. DQX Class II 1994-08-31
K942939 CORDIS STEADFAST MAGNETIC EXCHANGE SYSTEM Cordis Corp. DQO Class II 1994-08-31
K941937 PIKOS E 01-B Biotronik, Inc. DXY Class III 1994-08-30
K934000 SENTRY AQUEOUS GEL ECG ELECTRODES Sentry Medical Products, Inc. DRX Class II 1994-08-30
K932046 LIFE-TELL T.S.S. Raco Products Co. DXH Class II 1994-08-29
K941653 SARNS TURBO MEMBRANE OXYGENATOR MODIFICATION 3M Health Care, Sarns DTZ Class II 1994-08-24
K942488 MEDCUFF Med-Con, Inc. DXQ Class II 1994-08-23
K942382 MS AMPLATZ EXTRA STIFF GUIDE WIRE Meadox Surgimed, Inc. DQX Class II 1994-08-22
K942629 NCE REPLACEMENT BATTERIES National Custom Ent., Inc. DPS Class II 1994-08-18
K942154 SCHNEIDER TOTAL CROSS AND MATCH 35 PERCUTANEWOUS TRANSLUMINAL ANGIOPLASTY CATHETERS Boston Scientific Scimed, Inc. LIT Class II 1994-08-18
K934093 580CDR DISPLAY DRIVER Vidco, Inc. DXJ Class II 1994-08-18
K940984 CARDIOMETRICS DUALFLOW SWITCH BOX Cardio Metrics, Inc. DQX Class II 1994-08-18
K933755 SENSOR SHIELD, MODIFICATION Medical Taping Systems, Inc. DQA Class II 1994-08-16
K942377 TRANSTAR PRESSURE TRANSDUCER Medex, Inc. DPT Class II 1994-08-16
K941225 UNIVIX GOLD MEMBRANE OXYGENATION MODULE WITH DUROFLO II HEPARIN TREATMENT Baxter Healthcare Corp DTZ Class II 1994-08-16
K942650 BIG BEN Rud Riester GmbH & CO KG DXN Class II 1994-08-15
K940547 FLOW DIRECT THERMODILUT BALLOON CATH HEPARIN COATED J-Lloyd Medical, Inc. DYG Class II 1994-08-11
K940896 MEDFLATOR II(TM) DISPOSABLE INFLATION DEVICE Medex, Inc. MAV Class II 1994-08-11
K934385 MINIPACK 3100/3000 MODIFICATION Pace Tech, Inc. DXN Class II 1994-08-10
K940489 SIMON NITINOL FILTER Nitinol Medical Technologies, Inc. DTK Class II 1994-08-09
K940178 PERCOR STAT-DL 9.5 FR.34CC & 40CC /PERCOR STAT-DL 10.5 FR.40CC & 50CC INTRA-AORTIC BALLOON MODIFICATION Datascope Corp. DSP Class II 1994-08-09
K932208 EXTRACORPOREAL CIRCUIT W/DURAFLO II HEPARIN TREATM Baxter Healthcare Corp DWF Class II 1994-08-09
K942440 AFP CARDIAC PACING SYSTEM MODEL 283 Siemens-Pacesetter, Inc. DTB Class III 1994-08-08
K935166 FLOW DIRECTED MIKRO-TIP PRESSURE TRANSDUCER Millar Instruments, Inc. DXO Class II 1994-08-05
K942438 ALTAIR 6100 CASSETTE RECORDER Burdick, Inc. DSH Class II 1994-08-05
K940801 K-KLIP Katecho, Inc. DRX Class II 1994-08-03
K940167 DIAGNOSTIC I CATHETER Ep Technologies, Inc. DRF Class II 1994-08-02
K942150 CVD SMALL VESSEL BALLOON DILATION CATHETER Cardio-Dynamics, Inc. LIT Class II 1994-08-02
K940620 ROSSMAX INTERNATIONAL LIMITED ACCURACY BLOOD PRESSURE MONITOR Quality Systems Design, Inc. DXN Class II 1994-08-01
K935782 DTX AND DTX PLUS DISPOSABLE PRESSURE TRANSDUCERS AND ACCESSORIES Ohmeda Medical DXN Class II 1994-08-01
K942231 MICROVIEW II/MICRORAIL II CATHETERS Cardiovascular Imaging Systems, Inc. DQO Class II 1994-08-01
K942812 FLO-RESTER DISPOSABLE VESSEL OCCLUDER Bio-Vascular, Inc. DXC Class II 1994-08-01
K940425 IMAGYN MEDICAL INFLATION DEVICE WITH NON-INVASIVE PRESSURE TUBING Imagyn Medical, Inc. MAV Class II 1994-08-01
K942777 MINIMUS II; MINIMUS II COLOR; BABYPHON Rudolf Riester GmbH & Co. KG DXQ Class II 1994-07-27
K943457 AS/3 PRESSURE TEMPERATURE MODULE, M-PT Datex Division Instrumentarium Corp. DSK Class II 1994-07-27
K941839 DISPOSABLE SURGICAL CABLE Conmed Andover Medical, Inc. DSA Class II 1994-07-27
K940168 DIAGNOSTIC II CATHETER Ep Technologies, Inc. DRF Class II 1994-07-27
K931335 SCIMED(R) VENTURE(TM) INFUSION CATHETER Scimed Life Systems, Inc. KRA Class II 1994-07-27
K943461 VARIOUS TYPES OF MERCURIALS Rud Riester GmbH & CO KG DXN Class II 1994-07-27
K934292 WILLIAM HARVEY HF5000 MEMBRANE OXYGENATOR Minntech Corp. DTZ Class II 1994-07-26
K941995 NCE REPLACEMENT BATTERIES National Custom Ent., Inc. LDD Class II 1994-07-26
K941654 SARNS FILTERED VENOUS RESERVIOR MODIFICATION 3M Health Care, Sarns DTP Class II 1994-07-26
K932867 LIFE PULSE RESUSCITATION TIMER Green Field Medical Sourcing, Inc. PMK Class I 1994-07-25
K935083 PEDIATRIC DEFIB K-PADS Katecho, Inc. LDD Class II 1994-07-25
K935405 ARTERIAL EMBOLECTOMY J-Lloyd Medical, Inc. DXE Class II 1994-07-25
K941981 AXILLOBIFEMORAL GORE-TEX CASCULAR GRAFT,BIFURCATED W. L. Gore & Associates, Inc. DSY Class II 1994-07-20
K942925 CONMED ANDOVER MED ECG ELECTRODES Conmed Andover Medical, Inc. DRX Class II 1994-07-20
K941921 BIO-MEDICUS BIO-CONSOLE MODELS 540, 540A,B,C,D,E, & 550 Medtronic Bio-Medicus, Inc. DWA Class II 1994-07-20
K935232 HYDROTORQUE GUIDE WIRE Kingston Technologies, Inc. DQX Class II 1994-07-20
K936313 CMS-90 BLOOD PRESSURE MEASUREMENT ASSISTANT Prevention Sciences DXQ Class II 1994-07-20
K932203 VITALMAX 530 Pace Tech Medical Monitors, Inc. DQA Class II 1994-07-19
K933624 VITALMAX 4000 Pace Tech, Inc. MHX Class II 1994-07-19
K936282 TRANSIT INFUSION CATHETER (NEUROVASCULAR USE) Cordis Neurovascular, Inc. DQO Class II 1994-07-18
K942066 ACS HI-TORQUE EXTRA S'PORT GUIDE WIRE Advanced Cardiovascular Systems, Inc. DQX Class II 1994-07-18
K925038 PACING LEAD MODEL 1188T Siemens-Pacesetter, Inc. DTB Class III 1994-07-15
K940868 CORDIS OPTA 5(TM) PTA BALLOON CATHETER, MODIFICATION Cordis Corp. LIT Class II 1994-07-12
K941058 PROCATH PACING THRESHOLD CABLE Professional Catheter Corp. DSA Class II 1994-07-11
K931560 CARDIAC CATHETERIZATION TRAY Clinipad Corp. DQO Class II 1994-07-11
K934333 3M RED DOT 2237 STICKY GEL MONITORING ECG ELECTRODE 3M Medical Products Group DRX Class II 1994-07-07
K922455 EVERT-O-CATH CATHETER American Biomaterials Corp. DQO Class II 1994-07-07
K942010 VASCU-GUARD Bio-Vascular, Inc. DXZ Class II 1994-07-07
K941428 EXACTA PERCUTANEOUS INTRODUCER SHEATH Ohmeda Medical DYB Class II 1994-07-06
K932892 PASSIVE PLUS ENDOCARDIAL PACING LEADS VAR. MODELS Siemens-Pacesetter, Inc. DTB Class III 1994-07-06
K942736 CARBOMEDICS(R) PROSTHETIC HEART VALVE HOLDER HANDLE Carbomedics, Inc. DTJ Class I 1994-07-06
K936051 OMNI-CENTRAL STATION MONITOR Invivo Research, Inc. DRT Class II 1994-07-06
K911884 ADVANCE PRESSURE MONITOR/HIGH PRESSURE LINES Advance Medical Designs, Inc. DTL Class II 1994-07-05
K940493 HAND ANEROID SPHYGMOMANOMETER Welch Allyn, Inc. DXQ Class II 1994-07-01
K935510 VX4 RECORDING PULSE OXIMETER Vitalog Monitoring,Inc. DQA Class II 1994-07-01
K941404 IMPULSE 4000 DEFIBRILLATOR/TRANSCUTANEOUS PACER ANALYZER Hogan & Hartson DRL Class II 1994-06-29
K940126 AVECOR PRE-BYPASS FILTER Avecor Cardiovascular, Inc. KRJ Class II 1994-06-28
K940802 ZIPPREP ELECTRODE Aspect Medical Systems, Inc. DRX Class II 1994-06-22
K941289 PULSE OXIMETER Bci Intl., Inc. DQA Class II 1994-06-22
K941137 SCIMED TRIGUIDE GUIDING CATHETER Scimed Life Systems, Inc. DQY Class II 1994-06-22
K942329 HAND CONTROLLED SYRINGE Abbott Laboratories DQO Class II 1994-06-20
K936003 AFFINITY CVR Avecor Cardiovascular, Inc. DTN Class II 1994-06-20
K932894 620CSR DISPLAY DRIVER Vidco, Inc. DXJ Class II 1994-06-20
K935997 PLATINUM PLUS GUIDEWIRE Boston Scientific Corp DQX Class II 1994-06-17
K930876 SILICONE BIPOLAR LEAD MODELS 1136T, 1142T &1146T Siemens-Pacesetter, Inc. DTB Class III 1994-06-15
K942482 PRESSURE MONITORING EXTENSION Surgical Technologies, Inc. DQO Class II 1994-06-14
K941254 DYE MANAGEMENT SYSTEM Abbott Laboratories DQO Class II 1994-06-13
K935292 SCHNEIDER GUIDEZILLA SOFTIP GUIDING CATHETER Boston Scientific Scimed, Inc. DQY Class II 1994-06-10
K940586 K-SNAP Katecho, Inc. DRX Class II 1994-06-09
K925936 LIFEPAK 300 AUTOMATIC ADVISORY DEFRILLATOR Physio-Control Corp. MKJ Class III 1994-06-08

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