meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
46
Latest Decision
1990-07-06

Clearances · page 139 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K901691 CVIS INSIGHT 15MHZ CATHETERS FOR PERIPHERAL USE Cardiovascular Imaging Systems, Inc. DQO Class II 1990-07-06
K901074 CODE #94315 RETROGRADE CORONARY SINUS PERF CANNULA Dlp, Inc. DWF Class II 1990-07-06
K901624 SHILEY PLEXUS INTEGRAL RESERVOIR HOLLOW FIBER OXY. Shiley, Inc. DTZ Class II 1990-07-03
K901682 PTI ANASTOMARK(TM) CORONARY BYPASS GRAFT MARKERS Pioneering Technologies, Inc. DSY Class II 1990-07-03
K900246 CARDIOTEST EK 53 R, CARDIOGNOST EK 56/ EK 512 Ppg Industries, Inc. DSI Class II 1990-07-03
K902134 MINIX, MINIX ST, NEW IC: L74 Medtronic Vascular DXY Class III 1990-07-03
K896930 CARDIAC OUTPUT COMPUTER, MODEL COM-3 Baxter Healthcare Corp DXG Class II 1990-07-03
K901815 MODIFIED STERILIZATION OF INTRA-ART(TM) CORONARY Pioneering Technologies, Inc. DRE Class II 1990-07-03
K901535 MODIFIED MEDTRONIC CLASSIX MODEL 8438 PULSE GENE. Medtronic Vascular DXY Class III 1990-07-03
K901300 BIOPSY FORCEPS Portlyn Corp. DWZ Class II 1990-06-29
K902132 CUFF, BLOOD PRESSURE Buffalo Medical Specialties Mfg., Inc. DXQ Class II 1990-06-29
K895437 SCIMED CORONARY GUIDING CATHETER Scimed Life Systems, Inc. DQO Class II 1990-06-28
K900213 PACEMAKER PATIENT ADAPTOR MODULE (PPAM) Bomed Medical Mfg., Ltd. DSB Class II 1990-06-28
K901767 MODIFIED IVT PERIPHERAL ATHERECTOMY Intensive Technology, Inc. LIT Class II 1990-06-28
K901584 BIO-MEDICUS BIO CONSOLE MODELS 540 A B C Bio Medicus, Inc. DWA Class II 1990-06-28
K900319 SIEMENS SIRECUST 1481T, DIGITAL TELEMETRY SYSTEM Siemens Medical Electronics DSI Class II 1990-06-28
K900652 NAMIC PTCA Y-ADAPTOR North American Instrument Corp. DTL Class II 1990-06-26
K901391 DATASCOPE PTCA PERCUTANEOUS CATHETER INTRODUCER Datascope Corp. DYB Class II 1990-06-26
K902334 MONITOR, MODEL 2817 Esaote Biomedica Spa DXJ Class II 1990-06-26
K900512 SIEMENS ELEMA MODELS 4020T AND 4021T ADAPTERS Pacesetter Systems DTD Class II 1990-06-25
K900317 PACEMATE FLOW DIRECTED THERMAL DILUTION CATHETER Elecath KRB Class II 1990-06-22
K902586 GRI LASERGRAPH(TM) ECG PAPER Gri Medical Products, Inc. DSF Class I 1990-06-22
K896964 PLASMA TFE VASCULAR PROSTHESIS MODIFIED INSTRUC. Medtronic Vascular DSY Class II 1990-06-21
K901347 DATASCOPE SLIDEWIRE(TM) Datascope Corp. DQX Class II 1990-06-21
K902230 COLORADO COLOR IMAGING RECORDER Honeywell, Inc. DSF Class I 1990-06-19
K901071 PULSE OXIMETRY MODULE Marquette Electronics, Inc. DQA Class II 1990-06-19
K901884 7620 REMOTE CENTRAL STATION REPEATER Marquette Electronics, Inc. DXJ Class II 1990-06-12
K900386 ACS ADVANCED CONCEPT GUIDE WIRE Advanced Cardiovascular Systems, Inc. DQX Class II 1990-06-12
K901565 ATRAUMAX SURGICAL CLAMP MODEL FOG-5048, 75MM SIDE Applied Vascular Devices, Inc. DXC Class II 1990-06-12
K901402 VS-1 LEAD EXT. 033-302, 4.75MM 033-260, 033-458 Telectronics Pacing Systems, Inc. DTB Class III 1990-06-12
K901926 SORBA MODEL CIC-1000 W/NEW ELECTRODES Sorba Medical Systems, Inc. DXG Class II 1990-06-12
K901399 POWERBASE II (PB2) Nellcor, Inc. DQA Class II 1990-06-12
K900415 C.P.R. LANDMARC Can-Am Medical, Inc. LIX Class II 1990-06-12
K900321 DYNATRON 330 BODY COMPOSITION ANALYZER Dynatronics Laser Corp. DSB Class II 1990-06-11
K901250 PLEXUS 2(TM) INFANT HOLLOW FIBER OXYGENATOR Shiley, Inc. DTZ Class II 1990-06-11
K901224 INSITE STEERABLE GUIDEWIRE Lake Region Mfg., Inc. DQX Class II 1990-06-11
K901249 PLEXUS 3.5(TM) PEDIATRIC HOLLOW FIBER OXYGENATOR Shiley, Inc. DTZ Class II 1990-06-11
K902060 ESCORT MODEL 300 Medical Data Electronics DQA Class II 1990-06-11
K901231 RMI CARDIOPLEGIA DELIVERY KITS Research Medical, Inc. DWF Class II 1990-06-08
K901303 HORIZON SURGICAL LIGATING AND MARKING CLIP Horizon Surgical, Inc. DSS Class II 1990-06-05
K901771 SIEMENS SIRECUST 732, PATIENT MONITOR Siemens Medical Electronics DPS Class II 1990-05-30
K901018 MODIFIED TRANSLUMINAL BALLOON DILATATION CATHETERS Boston Scientific Corp LIT Class II 1990-05-30
K895899 FLEXMEDICS GUIDEWIRE .012 ONLY Flexmedics DQX Class II 1990-05-23
K901251 MODEL 9101 RECORDER/ANALYZER SYSTEM Aequitron Medical, Inc. DSH Class II 1990-05-22
K901452 USCI(R) ACCESS(TM) INTRODUCER SET C.R. Bard, Inc. DYB Class II 1990-05-22
K901709 DNP 60-B UNIPOLAR ENDOCARDIAL LEAD Biotronik, GmbH & Co. DTB Class III 1990-05-22
K900034 ANGIO-MAX Accumed Systems, Inc. DXT Class II 1990-05-22
K900910 COBE AIR EMBOLI PROTECTION SYSTEM (AEPS) Cobe Laboratories, Inc. DTW Class II 1990-05-22
K901774 HORIZON 2000 PULSE OXIMETRY (SAO2) MONITOR CAPABIL Mennen Medical, Inc. DQA Class II 1990-05-22
K892217 CAV SAT OXIMETER MODEL 100 Somanetics Corp. DQA Class II 1990-05-18
K897074 MODEL 215M PATIENT SIMULATOR Dynatech/Nevada, Inc. DSI Class II 1990-05-17
K901031 PCI MODEL 2041-PC TELEMETRY MONITOR Accucore, Inc. DRT Class II 1990-05-17
K896338 VOSS DISPOSABLE CORONARY BYPASS FLUSHING CANNULA Voss Medical Products DWF Class II 1990-05-17
K896020 EXTRACORPOREAL HEAT EXCHANGER HE SERIES Gish Biomedical, Inc. DTR Class II 1990-05-17
K900758 HEPARINIZED ARTERIAL SCREEN BLOOD FILTER Cobe Laboratories, Inc. DTM Class II 1990-05-17
K896775 PCI MODEL 2041-B TELEMETRY MONITOR Accucore, Inc. DSI Class II 1990-05-17
K901591 ESCORT-LINK (MODEL E3200) Medical Data Electronics DXH Class II 1990-05-15
K896040 KING OF HEARTS CDM Instromedix, Inc. DXH Class II 1990-05-15
K901060 EDENTEC MODEL 2000W SYSTEM 700 MONITOR Edentec Corp. DQA Class II 1990-05-15
K900879 SOFT-WEDGE(TM) SYRINGE Baxter Healthcare Corp DYG Class II 1990-05-10
K900797 STOCKERT SHILEY DUAL PRESSURE CONTROL MODULE XR Shiley, Inc. DXS Class II 1990-05-10
K900551 MATRX DISPOSABLE NON-INVASIVE GELLED PACING ELEC. Matrix Medica, Inc. DRS Class II 1990-05-09
K901506 ANEROID SPHYGMOMANOMETER, DOCTOR TYPE Yamasu Co. , Ltd. DXQ Class II 1990-05-09
K900657 UNIVERSAL DELIVERY SYSTEM CATHETER Microvena Corp. DQY Class II 1990-05-09
K901385 GABRIEL MEDICAL CLS THERMAL RECORDER Gabriel Medical, Inc. DSF Class I 1990-05-09
K901358 BARD BIOPOTENTIAL AMPLIFIER II C.R. Bard, Inc. DRQ Class II 1990-05-09
K901332 PK-55 ANDOVER MEDICAL PART #5455 LABEL CHANGE Biotronik, GmbH & Co. DTC Class II 1990-05-09
K900815 SARNS 9000 PERFUSION SYSTEM W/ALERT ONLY LEVEL 3M Company DTW Class II 1990-05-09
K894100 OXYTRAK(TM) PULSE OXIMETER Critikon Company, LLC DQA Class II 1990-05-09
K900765 STEEROCATH(TM) Ep Technologies, Inc. DRF Class II 1990-05-07
K896919 HEARTSTART 3000 Laerdal Medical Corp. MKJ Class III 1990-05-03
K900984 MODIFIED UNIPOLAR IMPLANT. PACING LEADS W/IS-1 Medtronic Vascular DTB Class III 1990-05-03
K895580 Y-ADAPTER W/THOUY BORST Angeion Corp. DYB Class II 1990-04-30
K901612 VITALMAX 2000 ECG MONITOR W/NON-INVASIVE BLOOD-PRE Pace Tech, Inc. DQA Class II 1990-04-30
K897121 QEKG ELECTROCARDIOGRAPH Qmed, Inc. DPS Class II 1990-04-30
K901209 MODEL 90489 PULSE OXIMETER MODULE Spacelabs, Inc. DQA Class II 1990-04-30
K900598 TRAMSCOPE SYSTEM Marquette Electronics, Inc. DPS Class II 1990-04-26
K900622 MODIFIED MODEL 5401B TEST CABLE Medtronic Vascular DXY Class III 1990-04-26
K897029 MODEL ECG100 SIMULATOR Dynatech/Nevada, Inc. DPS Class II 1990-04-26
K895180 USCI 7F LARGE LUMEN GUIDING CATHETER C.R. Bard, Inc. DQO Class II 1990-04-23
K896699 TYPE 9040/NEO S & W Medico Teknik DRT Class II 1990-04-20
K900550 FAST-PASS ACE MODELS 1212T/1222T/1216T/1226T Pacesetter Systems DTB Class III 1990-04-20
K894703 SIMON NITINOL FILTER Nitinol Medical Technologies, Inc. DTK Class II 1990-04-20
K900640 MODIFIED MP-4 CARDIOPLEGIA DELIVERY SYSTEM W/CONDU 3M Company DTR Class II 1990-04-20
K894664 CAPIOX HARDSHELL VENOUS RESERVOIR Terumo Medical Corp. DTN Class II 1990-04-20
K896700 TYPE 9140/NEO S & W Medico Teknik DRT Class II 1990-04-20
K900627 MODEL 5866-34 LEAD ADAPTOR KIT Medtronic Vascular DTD Class II 1990-04-20
K900281 SERIES 3001 IABP Boston Scientific Corp DSP Class II 1990-04-19
K900982 E-CLIP Joel Cohen & Esther R. Cohen LDF Class II 1990-04-19
K894401 BALLOON THERMODILUTION CATHETERS Worldwide Medical DQO Class II 1990-04-19
K901034 MODELS WEP-8410A AND WEP-8420A TELEMETRY CENTRAL Nihon Kohden America, Inc. DRT Class II 1990-04-19
K896862 MODEL 263 SPECTRASCAN(TM) HOLTER ANALYSIS SYSTEM Del Mar Avionics DSI Class II 1990-04-18
K897075 PTI INTRA-ART(TM) ANSARI SAPHENOUS VEIN HOLDER Pioneering Technologies, Inc. DXC Class II 1990-04-10
K900186 BONCHEK-SHILEY CARDIAC JACKET W/RECIRCULATION SET Shiley, Inc. DWJ Class II 1990-04-10
K900032 MODEL M1175A/M1176A WITH ST SEGMENT MONITORING Hewlett-Packard Co. DRT Class II 1990-04-10
K896096 SOLOSTICK (AMPLATZ DILATOR NEEDLE) Microvena Corp. DRE Class II 1990-04-10
K895433 ARIES 30CC & 50CC INTRA-AORTIC BALLOON & CONT. SYS Aries Medical, Inc. DSP Class II 1990-04-10
K900753 SHILEY VEIN IRRIGATION CANNULA (BEVELED & BLUNT) Shiley, Inc. DWF Class II 1990-04-10
K896438 UPSIZING LEAD ADAPTERS 5.0MM PEEL-AWAY ADAPTER Telectronics Pacing Systems, Inc. DTD Class II 1990-04-10
K895542 SONICATH(TM) 5 F Boston Scientific Corp DQO Class II 1990-04-06

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