meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
51
Latest Decision
1991-07-25

Clearances · page 134 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K912638 BLOOD PRESSURE CUFFS Vital Signs, Inc. DXQ Class II 1991-07-25
K912714 RT40 RADIO TRANSLUCENT Bio-Detek, Inc. DRX Class II 1991-07-25
K910634 DC200 DEFIBRILLATOR Siemens Burdick, Inc. LDD Class II 1991-07-24
K910905 SFA-II MICROPROCESSOR-CONTROLLED MODULE Life Sciences Manufacturing, Inc. DRQ Class II 1991-07-24
K911827 MODEL 5866-9M & MODEL 6981M Metronic, Inc. DTD Class II 1991-07-23
K911853 PULSATILE ANTI-EMBOLISM SYS.PUMP Baxter Healthcare Corp JOW Class II 1991-07-22
K911935 CARDIAC ELECTROPHYSICAL LEAD SELECTOR, MODIFIED Gould, Inc. DRR Class II 1991-07-22
K912007 BAXTER SINGLE PATIENT USE BLOOD PRESSURE CUFF Tecnadyne Scientific, Inc. DXQ Class II 1991-07-22
K911794 CATH SHEATH INTRODUCER SYST PLUS W/UNISTASIS VALVE Cordis Corp. DYB Class II 1991-07-19
K903512 FUTURECARE CARELYNK IV SYSTEM Futurecare Systems, Inc. DRT Class II 1991-07-18
K910001 MODEL 8604-FO PULSE OXIMETER Nonin Medical, Inc. DQA Class II 1991-07-18
K911549 INJECTOR FILL TUBE The R Group DXT Class II 1991-07-18
K904966 DATAMED MODEL 401A TRANSRECIEVER Datamed, Inc. DXH Class II 1991-07-18
K903237 CARDIOCAP CMX-104 MONITOR Datex Division Instrumentarium Corp. DXN Class II 1991-07-17
K910144 12-LEAD ECG ADAPTOR FOR USE W/LIFEPAK 10 DEFIB/MON Physio-Control Corp. LDD Class II 1991-07-17
K905274 VITALMAX 2100/2200 Pace Tech, Inc. DRT Class II 1991-07-17
K910808 Q-SMART HOLTER SYSTEMS Quinton, Inc. DSI Class II 1991-07-17
K910840 VASCULAR BIOPSY FORCEPS Vascular Products, Inc. DWZ Class II 1991-07-15
K910958 MEDFLATOR INFLATION SYSTEM Medex, Inc. MAV Class II 1991-07-12
K911678 ROTATING HEMOSTATIC VALVE Devices For Vascular Intervention, Inc. DYB Class II 1991-07-12
K911295 ANGIOPLASTY INFLATOR Vastek MAV Class II 1991-07-12
K910429 SWAN-GANZ FLOW DIRECTED PRESSURE TD CATHETER Baxter Healthcare Corp DXO Class II 1991-07-11
K911616 HORIZON XL Mennen Medical, Inc. DRT Class II 1991-07-10
K900385 ACTA METRA/ACTA GNOSIS FIRMWARE PACKAGE Parexel Intl. Corp. DSI Class II 1991-07-09
K905698 CORDIS OPTA 5 Cordis Corp. LIT Class II 1991-07-09
K911605 TRACKER UNIBODY, UNIBODY W/SIDE & 25 SIDE HOLES Target Therapeutics DQO Class II 1991-07-09
K911632 CAPIOX(R) BUBBLE TRAP Terumo Medical Corp. KRL Class II 1991-07-09
K911560 ZEPHYR INFUSION CATHETER Target Therapeutics DQO Class II 1991-07-05
K911547 MAGNUM-MEIER RECANALIZATION GUIDEWIRE Schneider Intl., Ltd. DQX Class II 1991-07-05
K911475 LAPAROSCOPIC VESSEL ARTICULATOR United States Endoscopy Group, Inc. DWP Class II 1991-07-02
K911483 LAPAROSCOPIC TROCAR United States Endoscopy Group, Inc. DRC Class II 1991-07-02
K911703 CORDIS 8 FRENCH 0.084 I.D. PTCA GUIDING CATHETER Cordis Corp. DQO Class II 1991-06-28
K912128 MAXI-SCOPE OR ULTRA-SCOPE Seiichi Mfg., Inc. LDE Class I 1991-06-28
K911460 .010 HI-TORQUE GUIDE WIRES WITH PRESHAPED TIP Advanced Cardiovascular Systems, Inc. DQX Class II 1991-06-25
K911384 CATHSCANNER(R) VISIONS(TM) 3.5F 54700/5.0F 54600 Endosonics Corp. DXK Class II 1991-06-25
K911099 MEHIGAN-PILLING ANGIOSCOPIC VASCULAR INSTRUM. LINE Pilling Co. DWX Class II 1991-06-25
K910116 TURBO SUPPORT CATHETER Datascope Corp. DQY Class II 1991-06-25
K912544 BIPOLAR FORCEPS Everest Medical Corp. MAV Class II 1991-06-24
K910916 CATHLAB SILICONE OCCLUSION BALLOON CATHETER Cathlab Corp. DQT Class II 1991-06-24
K911100 MEHIGAN-PILLING PHLEBETOME TM Pilling Co. MGZ Class II 1991-06-21
K904298 EURO-DIAGNOSTIC BLOOD PRESSURE MONITOR Medi-Swiss Corp. DXN Class II 1991-06-21
K911990 ECG FEMALE-TO-PIN SNAP ELECTRODE W/LEADS AND EXT. Somnitec, Inc. DRX Class II 1991-06-21
K903966 EXTERNAL PACEMAKER ANALYZER MODEL PMA-1 Bio-Tek Instruments, Inc. DTC Class II 1991-06-19
K905313 KONTRON INTRA-AORTIC BALLOON PUMP, MODEL KAAT II Kontron Instruments, Inc. DSP Class II 1991-06-19
K911236 MEDTRONIC PERMANENT LEAD INTRODUCER, VARIOUS MDLS Medtronic Vascular DYB Class II 1991-06-18
K912379 PDT CARRYALL TRANSMITTER, VARIOUS MODELS Cardiac Pacemakers, Inc. DXH Class II 1991-06-17
K911139 HEWLETT-PACKARD MODELS M1400A, M1402A & M1401A Hewlett-Packard Co. DRT Class II 1991-06-11
K911639 OPTI-PLAST 5F PTA CATHETERS OVEN CURING PROCEDURE Vas-Cath, Inc. LIT Class II 1991-06-11
K905056 PERCOR STAT-DL 9.5 FR W/OPT INSERT W/O INTRO SHEAT Datascope Corp. DSP Class II 1991-06-11
K911310 COROMETRICS 5566AAX NONINVASIVE BLOOD PRESSURE MOD Ge Medical Systems Information Technologies DXN Class II 1991-06-10
K910451 CARD GUARD, MODEL CG-2000A Medtech Industries, Inc. DXH Class II 1991-06-10
K911367 BAXTER MARATHON(TM) INTRAVASCULAR RELAY GUID CATH Baxter Healthcare Corp DQO Class II 1991-06-10
K905500 MYOCARDIAL PROTECTION SYSTEM Medtronic Vascular DTR Class II 1991-06-10
K911196 SCHNEIDER TOTAL CROSS .021 PERCU TRANS ANGIO (PTA) Schneider Intl., Ltd. LIT Class II 1991-06-10
K911191 PALCO LABS MODEL 300 OXYGEN/PULSE MONITOR Palco Laboratories, Inc. DQA Class II 1991-06-10
K911124 503 PULSE OXIMETER Criticare Systems, Inc. DQA Class II 1991-06-07
K905818 VACUUM-ASSISTED BLOOD COLLECTION SYSTEM Jtl Medical Corp. DTN Class II 1991-06-06
K911130 HEMOSTATIC Y CONNECTOR Thomas Medical Products, Inc. LIT Class II 1991-06-06
K911215 GESCO PER-Q-CATH NEEDLE Gesco Intl., Inc. LIT Class II 1991-06-06
K905788 MODEL M1251A MON. FULL DISCLOSURE REVIEW SYSTEM Hewlett-Packard Co. DXJ Class II 1991-06-06
K910933 OLYMPUS ANGIOSCOPY IRRIGATION SHEATH Olympus Corp. DYB Class II 1991-06-03
K911840 INTERFLO MEDICAL MODEL PA3-H CCO/PAC CATHETER Intec Medical, Inc. DYG Class II 1991-06-03
K901454 VENA CAVA FILTER Vena-Tech, Inc. DTK Class II 1991-05-29
K910987 7FR. AND 8FR. TRIGUIDE GUIDING CATHETER ADD. CURVE Scimed DQO Class II 1991-05-29
K911227 NEW STERILITY CHARACTER/SARNS OXYGENATOR PRODUCTS 3M Health Care, Sarns DTZ Class II 1991-05-29
K911089 STEALTH CATHETER SYSTEM Target Therapeutics LIT Class II 1991-05-29
K910873 BD ANGIOGRAPHIC SYRINGE W/A ROTATING TIP Bd Becton Dickinson Vacutainer Systems Preanalytic DXT Class II 1991-05-29
K910339 AVD INTIMAX OCCLUSION CATHETER Applied Vascular Devices, Inc. DQT Class II 1991-05-29
K905140 SATLITE PLUS PULSE OXIMETER Datex Division Instrumentarium Corp. DQA Class II 1991-05-28
K910188 FLOWPLUS AC330 PUMP GARMENTS Huntleigh Technology, Inc. JOW Class II 1991-05-28
K905310 MINIOX V PULSE OXIMETER Catalyst Research Corp. DQA Class II 1991-05-28
K904355 CARDIOCAP II TM CH-RESP MONITORS Instrumentarium Corp. DPS Class II 1991-05-23
K910021 CARDIOPULMONARY BYPASS PUMP TUBING Jtl Medical Corp. DWF Class II 1991-05-22
K911519 CATHCAP, CAT. NO. CC100 SERIES Gish Biomedical, Inc. DQY Class II 1991-05-22
K910845 ITC ROTATING HEMOSTATIC VALVE CAT. NO. MX 1012 Interventional Therapeutics Corp. DTL Class II 1991-05-21
K910935 MODIFIED PYROGEN TESTING Electromedics, Inc. DTM Class II 1991-05-16
K905824 MAESTRO(R) SERIES 100/200 CARDIAC S/CHAMB PACEMAKE Cardiac Control Systems, Inc. DXY Class III 1991-05-16
K910969 TORQUE DEVICE FOR A GUIDE WIRE Terumo Corp. DQX Class II 1991-05-16
K910221 RMI VASCULAR TOURNIQUET KIT Research Medical, Inc. DXC Class II 1991-05-16
K910688 CORDIS PEEL-AWAY INSERTION TOOL Cordis Corp. DYB Class II 1991-05-16
K904868 XEMEX TEMPORARY PACING CATHETER A Zeon Medical Corp. LDF Class II 1991-05-16
K910327 WARMAIR SYSTEM Cincinnati Sub-Zero Products, Inc. DWJ Class II 1991-05-16
K911122 8MM QUANTUM PULSE/SUPRIMA II PULSE GENERATORS Intermedics, Inc. DXY Class III 1991-05-16
K910629 AP-860PA NIBP MODULE Nihon Kohden America, Inc. DQA Class II 1991-05-14
K910770 504US PULSE OXIMETER Criticare Systems, Inc. DQA Class II 1991-05-14
K910281 INTRAVASCULAR IMAGING SYSTEM/MODIFIED Intertherapy, Inc. JOP Class II 1991-05-13
K910882 PROPAQ 102EL, 104EL AND 106EL Protocol Systems, Inc. DRT Class II 1991-05-08
K910903 INFLATE-A-CUFF #7014 Pa Medical Corp. DXQ Class II 1991-05-08
K910682 ROBICSEK PROBE/RETRACTOR Bio-Vascular, Inc. DWP Class II 1991-05-08
K910754 MODEL 43100A SERIES DEFIBRILLATOR, MODIFICATION Hewlett-Packard Co. LDD Class II 1991-05-08
K910620 CARDIOCAP DR-124 RECORDER Datex Division Instrumentarium Corp. DRG Class II 1991-05-07
K905300 PERMANENT PACING LEAD Oscor Medical Corp. DTB Class III 1991-05-07
K905114 A.P.GRAPH III(TM) CARDIOVASCULAR ANALYZER Research Consultants, Inc. JOM Class II 1991-05-07
K905087 TRIOS 02 Biotronik, GmbH & Co. DXY Class III 1991-05-07
K911140 BARD(R) ENDOCARDIAL BALLOON ARRAY C.R. Bard, Inc. DRF Class II 1991-05-07
K910450 CARD GUARD-3000 ECG TELEPHONE ADAPTER Medtech Industries, Inc. DXH Class II 1991-05-07
K910645 DISPOSABLE PATIENT CABLE Diag Corp. DSA Class II 1991-05-07
K910595 MODEL 5311B A-V PACING SYSTEM ANALYZER Medtronic Vascular DTC Class II 1991-05-07
K905182 OSCOR MEDICAL CORP. PERMANENT PACING PAD Oscor Medical Corp. DTB Class III 1991-05-07
K910861 PERCUTANEOUS INTROD W/SIDEPORT/THREE-WAY STOPCOCK Daig Corp. DYB Class II 1991-05-07

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