meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
44
Latest Decision
1993-06-25

Clearances · page 127 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K931514 SCIMED(R) ENTRE(TM) II PTCA GUIDE WIRE & ACCESSORY Scimed Life Systems, Inc. DQX Class II 1993-06-25
K922891 CORDIS 7 FRENCH THRULUMEN CATHETER Cordis Corp. DQO Class II 1993-06-23
K931577 SCHNEIDER MAGNUM PERIPHERAL RECANALIZATION GUIDEWI Schneider Intl., Ltd. DQX Class II 1993-06-23
K930004 ESCORT 100/300 SERIES B PATIENT MONITORS Medical Data Electronics DRT Class II 1993-06-23
K924529 SIGNATURE(TM) CUSTOM TUBING PACK Avecor Cardiovascular, Inc. DWF Class II 1993-06-23
K925639 CARDIOMAGIC SOFTWARE Instromedix, Inc. DXH Class II 1993-06-22
K930299 BARD(R) BLOOD CARDIOPLEGIA HEAT EXCHANGER/TUBE SET C.R. Bard, Inc. DTN Class II 1993-06-22
K926226 INTERSEPT FILTERED CARDIOTOMY RESERVOIR Medtronic Vascular DTZ Class II 1993-06-22
K925099 POSSIS MEDICAL MYOPORE BIPOLAR SUTURELESS MYCARDIA Possis Medical, Inc. DTB Class III 1993-06-22
K926138 CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING Baxter Healthcare Corp KRH Class II 1993-06-22
K924187 INSTANT MEMORY 2000 Telescan Medical Systems DXH Class II 1993-06-16
K925608 SCIMED ENCORE(TM) ADVANTAGE KIT/ESSENTIALS KIT Scimed Life Systems, Inc. MFY Class II 1993-06-16
K925852 TERUMO CORONARY GUIDE WIRE Terumo Medical Corp. DQX Class II 1993-06-10
K925347 MODEL 1148T TRANSVENOUS, SCREW-IN LEAD Siemens-Pacesetter, Inc. DTB Class III 1993-06-10
K925076 SARNS TURBO MEMBRANE OXYGENA. W/INT. CARDIOTOMY R. 3M Health Care, Sarns DTZ Class II 1993-06-07
K926271 SCHNEIDER MATCH-35 PERCUTANEOUS TRANSLUMINAL ANGIO Schneider Intl., Ltd. LIT Class II 1993-06-07
K925075 SARNS TURBO MEMBRANE OXYGENA. W/INT. RESERVOIR 3M Health Care, Sarns DTZ Class II 1993-06-07
K926003 SCHNEIDER SOFTIP SST ANGIOGRAPHIC (DIAG) CATHETER Schneider Intl., Ltd. DQO Class II 1993-06-07
K924891 PLEXUS PULSER I, PLEXUS PULSER II Dobre, Inc. JOW Class II 1993-06-07
K931171 DOC-TITE(TM) GUIDE WIRE EXTENSION Advanced Cardiovascular Systems, Inc. DQX Class II 1993-06-04
K926233 CARDIO2 CYCLE Ergometrix, Inc. KRI Class I 1993-06-04
K930311 CVIS LONGVIEW Cardiovascular Imaging Systems, Inc. DQO Class II 1993-06-02
K926357 MEDTRONIC BIO-MEDICUS HANDCRANK MODEL 150 Medtronic Bio-Medicus, Inc. DWA Class II 1993-06-02
K931087 CLEANCUFF(TM) Med-Con, Inc. DXQ Class II 1993-05-27
K926340 NEW LEAD INTRODUCER KITS, VARIOUS MODELS Telectronics Pacing Systems, Inc. DYB Class II 1993-05-27
K931386 HEMASHIELD MICROVEL/WOVEN DOUBLE VELOUR FABRIC Meadox Medicals, Div. Boston Scientific Corp. DXZ Class II 1993-05-27
K931102 CORDIS NIHON CATHETER SHEATH INTRODUCER Cordis Corp. DYB Class II 1993-05-27
K915699 NELLCOR PORTABLE PULSE OXIMETER MODEL N-20 Nellcor, Inc. DQA Class II 1993-05-27
K925123 ATRIUM'S HYBRID PTFE Atrium Medical Corp. DSY Class II 1993-05-27
K925979 DUAL LUMEN L-CATH CATHETER SYSTEM Luther Medical Products, Inc. DQX Class II 1993-05-27
K930961 CATHETER GUIDEWIRE (PERIPHERAL USE) Target Therapeutics DQX Class II 1993-05-26
K924125 CRI ELECTRONIC CONTROL SYSTEM Catheter Research C/O Burditt, Bowles & Radzius DXX Class II 1993-05-26
K921388 BIOCHEM 9100 MULTIGAS MONITOR IBP MODULE Biochem International, Inc. DSK Class II 1993-05-26
K930011 URESIL VALVE CUTTER WITH INTERCHANGEABLE HEADS Uresil Corp. MGZ Class II 1993-05-26
K914751 SELECTIVE INFUSION II CATHETER Advanced Cardiovascular Systems, Inc. KRA Class II 1993-05-24
K925899 AMBULATORY BLOOD PRESSURE MONITOR, MDL# 5100-01 Welch Allyn, Inc. DSK Class II 1993-05-21
K925442 SARNS RETROGRADE CANNULA 3M Health Care, Sarns DWF Class II 1993-05-21
K921706 MEADOX(R) SURGIMED OLBERT CATHETER SYSTEM(R) Meadox Medicals, Div. Boston Scientific Corp. LIT Class II 1993-05-20
K924358 ACCEMT DG(TM) BALLOON ANGIOPLASTY CATH, MODIFIED Cook, Inc. LIT Class II 1993-05-20
K910599 CARDIOPULMONARY BYPASS LEVEL SENSING MONITOR Jtl Medical Corp. DTW Class II 1993-05-20
K925945 MAVERICK PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CAT Scimed Life Systems, Inc. LIT Class II 1993-05-20
K923621 EXTERNAL DEMAND PACEMAKER Oscor Medical Corp. DTE Class II 1993-05-19
K922034 LV-20 VOLUMETER, 20 MHZ DOPPLER BLOOD FLOW METER Titronics Medical Instruments, Inc. DPW Class II 1993-05-18
K931053 LIFEPAK 10 DEFIBRILLATOR/MONITOR W/OPT PACEMAKER Physio-Control Corp. LDD Class II 1993-05-18
K925661 STOCKERT CAPS1 CARDIOPLEGIC CONTROL MODULE Sorin Biomedica, Fiat, USA, Inc. KRL Class II 1993-05-18
K922840 ANTEGRADE/RETROGRADE CARDIOPLEGIA VALVE SYSTEMS Gish Biomedical, Inc. DTL Class II 1993-05-17
K930770 MEDTRONIC MINIX & MINIX ST PULSE GENERATORS Medtronic Vascular DXY Class III 1993-05-14
K923868 CCS MAESTRO II SERIES 200 CARDIAC PACEMAKER Cardiac Control Systems, Inc. DXY Class III 1993-05-14
K924910 SYSTEM 7500 NIBP/SA02 Advanced Medical Instruments, Inc. DXN Class II 1993-05-13
K920178 CARDIOTOMY RESERVOIR W/20 MICRON FILITER Lifestream Int'L, Inc. DTN Class II 1993-05-13
K930798 OMRON OSCILLOMETRIC DIGITAL BLOOD PRESSURE MONIT. Omron Healthcare, Inc. DXN Class II 1993-05-13
K923272 COBE CMS-HF HOLLOW FIBER MEMBRANE OXYGENATOR Cobe Laboratories, Inc. DTZ Class II 1993-05-11
K920902 MODIFICATION OF SARNS TWO STAGE VENOUS CANNULA 3M Health Care, Sarns DWF Class II 1993-05-11
K930684 BARD WILLIAM HARVEY TWO STAGE CANNULA C.R. Bard, Inc. DWF Class II 1993-05-11
K924285 MODEL 3500 MR-COMPATIBLE PULSE OXIMETER Magnetic Resonance Equipment Corp. DQA Class II 1993-05-11
K921930 SIEMENS SIRECUST 700 BEDSIDES/ACCESSORIES, MODIFI Siemens Medical Electronics DPS Class II 1993-05-07
K924282 MODEL 320 MR-COMPATIBLE PULSE OXIMETER Magnetic Resonance Equipment Corp. DQA Class II 1993-05-07
K930620 BARD(R) WILLIAM HARVEY(R) ARTERIAL STRAIGH CANNULA C.R. Bard, Inc. DWF Class II 1993-05-07
K924206 MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 540E Medtronic Bio-Medicus, Inc. DWA Class II 1993-05-07
K925717 CALF GARMENT DVT10(S) COMPRESSIBLE LIMB SLEEVE Huntleigh Healthcare, Inc. JOW Class II 1993-05-07
K925131 CORDIS 9 F GUIDING CATHETER Cordis Corp. DQY Class II 1993-05-06
K930593 BARD WILLIAM HARVEY AORTIC ROOT CARDIOPLEGIA CANNU C.R. Bard, Inc. DWF Class II 1993-05-06
K925342 MEDTRONIC INTERVENTIONAL VASCULAR SHERPA GUIDEWIRE Medtronics Interventional Vascular DQX Class II 1993-05-06
K924205 MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 550 Medtronic Bio-Medicus, Inc. DWA Class II 1993-05-06
K925346 EP AMP, MODEL #901 Quinton Electrophysiology Corp. DRR Class II 1993-04-30
K922609 ITC CATHETERS W/ HYDROMER Interventional Therapeutics Corp. DQY Class II 1993-04-30
K930604 BALANCED(TM) NYLON BLADDER Pymah Corp. DXQ Class II 1993-04-30
K922042 CARDIFIX ENDOCARDIAL PACING LEAD Intermedics, Inc. DTB Class III 1993-04-29
K930622 AMPLATZ GUIDEWIRES Meadox Medicals, Div. Boston Scientific Corp. DQX Class II 1993-04-29
K922235 SYSTEM 97 Datascope Corp. DSP Class II 1993-04-27
K930558 MORTARA INSTRUMENT, INC. E-SCRIBE Mortara Instrument, Inc. DPS Class II 1993-04-27
K922703 THE ACTA FORMULA Biosound, Inc. DPS Class II 1993-04-27
K924607 ARROW FISCHELL KINK RESIST PERCUT SHEATH INTRO SET Arrow Intl., Inc. DYB Class II 1993-04-22
K930479 NYLEX CATHETERS Cordis Corp. DQO Class II 1993-04-21
K925046 PLEUR-EVAC CARDIOTOMY RESERVOIR Deknatel, Inc. DTN Class II 1993-04-20
K930258 TRACET T-6000 Lectec Corp. DRX Class II 1993-04-16
K926175 K-DEFIB/PACE CARBON ELECTRODE Katecho, Inc. DRO Class II 1993-04-15
K930134 9055 IRCA OPTION FOR SYSTEM ATHENA 9050 NT S & W Medico Teknik DPS Class II 1993-04-09
K926457 SCIMED(R) 0.038 CONTROLWIRE(TM) PERIPHER GUIDE WIR Scimed Life Systems, Inc. DQX Class II 1993-04-08
K924661 SWAN-GANZ INTELLICATH CCO THERMODILUTION CATHETER Baxter Healthcare Corp KRA Class II 1993-04-08
K923368 MAGIC INFUSION CATHETER Target Therapeutics KRA Class II 1993-04-07
K924382 BARD(R) INTRA AORTIC BALLOON C.R. Bard, Inc. DSP Class II 1993-04-07
K930091 CORDIS REFLEX STEERABLE GUIDEWIRE Cordis Corp. DQX Class II 1993-04-07
K914791 GISH ARTERIAL FILTER Gish Biomedical, Inc. DTM Class II 1993-04-06
K922210 HEWLETT-PACKARD MODEL 78730 CAREVUE 5000 Hewlett-Packard Co. MHX Class II 1993-04-01
K925369 BCD ADVANCED BLOOD CARIOPLEGIA SYSTEMS Sorin Biomedica, Fiat, USA, Inc. DTR Class II 1993-03-26
K924642 MEDTRONIC BIO-MEDICUS FEMORAL CANNULA/INTRODUCER Medtronic Bio-Medicus, Inc. DWF Class II 1993-03-26
K926421 ACS ET HI-FLOW/ENHANCED TORQUE CORONARY GUID CATH Advanced Cardiovascular Systems, Inc. DQY Class II 1993-03-23
K924456 LONG LENGTH PERCUTANEOUS INTRODUCER SET Thomas Medical Products, Inc. DYB Class II 1993-03-22
K923483 BARD WILLIAM HARVEY AORTIC ARCH CANULAE C.R. Bard, Inc. DWF Class II 1993-03-22
K921164 MODEL 1300 SOFTRACE II ELECTRODE Medtronic Vascular DRX Class II 1993-03-18
K921757 ANGEION IGITAL ANGEFLATOR Angeion Corp. MAV Class II 1993-03-18
K922742 HPM 40 HEART PACEMAKER MONITOR Biotronik, GmbH & Co. KRE Class II 1993-03-18
K920594 SHILEY PERFUSION TUBING SETS Shiley, Inc. DTM Class II 1993-03-18
K924338 ARROW-FISCHELL EXTENDED VASCULAR ACCESS NEEDLE Arrow Intl., Inc. DRC Class II 1993-03-18
K920066 PALCO LABS MODEL 340 PULSE OXIMETER Palco Laboratories, Inc. DQA Class II 1993-03-16
K922471 SARNS RETROGRADE CANNULA - AUTO INFLATE 3M Health Care, Sarns DWF Class II 1993-03-12
K921649 RETRIEVER 10 Target Therapeutics DQO Class II 1993-03-11
K922781 FLOW CONROL VALVE American Omni Medical, Inc. MJJ Class II 1993-03-08
K923603 INTRA-AORTIC BALLOON PUMP CATHETER - MODIFICATION Kontron Instruments, Inc. DYB Class II 1993-03-08

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