meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
41
Latest Decision
1983-02-07

Clearances · page 173 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K823712 BEL BLOOD LEVEL DETECTOR R. Scott Bell DTW Class II 1983-02-07
K830131 ARTERIAL BLOOD FILTER AF-1025-AF-1025BL American Bentley DTM Class II 1983-01-28
K830097 AUFRANC-TURNER ATS METAL BACKED ACETABU Howmedica Corp. DXQ Class II 1983-01-28
K830093 USCI ELECTRONIC MANOMETER C.R. Bard, Inc. DRS Class II 1983-01-28
K830132 ARTERIAL BLOOD FILTER AF-1040-AF-1040BL American Bentley DTM Class II 1983-01-28
K823064 INTRACATH-DA INTRAVENOUS CATH. PLACEMENT Parke-Davis Co. DQO Class II 1983-01-27
K823268 MODEL 78670A Hewlett-Packard Co. LDD Class II 1983-01-26
K823342 PERCOR INTRA-AORTIC BALLOON INSERTION Datascope Corp. DSP Class II 1983-01-24
K823243 SIDEARM Y-ADAPTOR American Edwards Laboratories DQO Class II 1983-01-21
K830028 SIRECUST 456 Analogic Corp. DXH Class II 1983-01-21
K823501 ZEE SPHYGMOMANOMETER Zee Medical Products Co., Inc. DXN Class II 1983-01-21
K830022 S.M.P. CONTRAST MEDIA SET Omega Technologies, Inc. DQO Class II 1983-01-21
K823262 MODEL SP5800 #8 FRENCH INTRO. KIT Gould, Inc. DYB Class II 1983-01-18
K823451 CLEAR CARDIOPLEJIA DELIVERY SYSTEM 3M Health Care, Sarns DTR Class II 1983-01-14
K823361 SWITCHING UNIT ELECTRODE CATHETERS Webster Laboratories, Inc. DRF Class II 1983-01-14
K823508 LIFELINE -UNIPOLAR LEAD #487-05 Intermedics, Inc. DTB Class III 1983-01-14
K822362 ALTA II ECG RECORDER Scole Engineering Co. DSH Class II 1983-01-14
K821717 GORE-TES EXPANDED PTFE PATCH W. L. Gore & Associates, Inc. DXZ Class II 1983-01-12
K823452 ELECTRODE LEAD OF SILICONE ELASTOMETER Telectronics, Inc. DTB Class III 1983-01-08
K823359 OXYGEN CONSUMPTION MONITOR #OCM-0100 Bentley Laboratories, Inc. DRY Class II 1983-01-05
K823731 CARDF Shiley, Inc. DTP Class II 1983-01-05
K823273 BOS-2S, SPIRAFLO BUBBLE INFANT OXYGEN. Bentley Laboratories, Inc. DTZ Class II 1983-01-05
K823197 MODEL 8300 TESTER Medicon, Inc. DRT Class II 1982-12-30
K823238 INJECTION FILL TUBE Vetrex Medical Corp. DXT Class II 1982-12-30
K822818 HOLTER RECORDER & PLAYBACK/ANALYSIS SYS Marquette Electronics, Inc. DSH Class II 1982-12-30
K823340 CLEAR VINYL MONITORING CONNECTOR Vertex Medical Corp. DXT Class II 1982-12-30
K823286 MODELS DPT 1000/DPT 1000NS Bio-Med Corp. DRS Class II 1982-12-30
K823414 HOLTER KIT MODEL #5000 SERIES Andover Medical, Inc. DSH Class II 1982-12-30
K823435 MON-A-THERM MYOCARDIAL TEMP. SENSOR Burditt & Calkins-Siemens-Elema KRB Class II 1982-12-30
K823272 VENOUS RESERVOIR BAG #BMR-1400 Bentley Laboratories, Inc. DTN Class II 1982-12-30
K823192 TUOHY-BORST ADAPTER W/SIDE ARM Vertex Medical Corp. DXT Class II 1982-12-30
K823584 FUKUDA DENSHI 6-CHANNEL AUTO. ELECTRO- Brentwood Instruments, Inc. DPS Class II 1982-12-30
K823456 OXYGENATORS #BOS-10, 105, 5S Bentley Laboratories, Inc. DTZ Class II 1982-12-30
K823533 JACKET & SET Shiley, Inc. DTR Class II 1982-12-30
K823191 DISPOSABLE PLASTIC STOPCOCK Vertex Medical Corp. DXT Class II 1982-12-30
K823033 ELECTRODE, PACEMAKER, PERMANENT Pacesetter Systems DTB Class III 1982-12-30
K823488 ELECTROCARDIOGRAPH #334 Birtcher Corp. DPS Class II 1982-12-30
K823253 VERTEX MONITORING CATHETER Vertex Medical Corp. DXT Class II 1982-12-30
K823190 BACKSTOP VALVE W/SIDE ARM Vertex Medical Corp. DXT Class II 1982-12-30
K823254 REUSABLE METAL STOPCOCK Vertex Medical Corp. DXT Class II 1982-12-30
K823290 NEUROMEDICS PACETRON HEART RATE MONITOR Intermedics, Inc. DRT Class II 1982-12-30
K823256 ULTRA-ASEPT ANGIOGRAPHIC SYRINGE/SPARE Vertex Medical Corp. DXT Class II 1982-12-30
K821826 FEP-RINGED GORE-TEX@ VASCULAR GRAFT W. L. Gore & Associates, Inc. DYF Class II 1982-12-29
K823678 TELEMETRY DECODER #540-02 Intermedics, Inc. DXY Class III 1982-12-22
K823484 THERMAL DILUTION CATHETER Instrumentation Laboratory CO DYG Class II 1982-12-22
K823281 MODEL RM 6000, 6100,6200 POLYGRAPH Nihon Kohden America, Inc. DPS Class II 1982-12-22
K823371 DURAPULSE Cpm International, Inc. DXY Class III 1982-12-22
K822000 EXTRACORPOREAL BLOOD GAS SYSTEM Cardiovascular Devices, Inc. DTY Class II 1982-12-22
K821951 DATASCOPE MODEL 83 IABP SYSTEM Datascope Corp. DSP Class II 1982-12-21
K822978 MINGOGRAF 4, MINGO CARD 4 & MINOCARD 3 Siemens Corp. DSF Class I 1982-12-15
K823094 CARDIAC ELEVATOR Cardio Surgical Research, Inc. DWS Class I 1982-12-15
K822791 CORATOMIC #VX5-105 & VX5-205 PULSE GEN. Coratomic, Inc. DXY Class III 1982-12-15
K822968 ELECTROCARDIOGRAPH INTERPRETER Suzuken Co., Ltd. DSI Class II 1982-12-15
K823343 OXYGENATOR 10 Gambro, Inc. DTZ Class II 1982-12-15
K822843 HTS *1 Global Office Automation System, Inc. DSK Class II 1982-12-15
K823048 SEA MED MODEL 880 Seamed Corp. DTE Class II 1982-12-15
K823529 FULL-DISCLOSURE AMBULATORY ECG SYSTEM Clinical Data, Inc. DPS Class II 1982-12-15
K823065 INTRA CATH-DSA INTRAVENOUS CATH PLACE. Parke-Davis Co. DQO Class II 1982-12-15
K823177 SMEC BALLOON SYSTEM Smec, Inc. DSP Class II 1982-12-15
K823446 PRODUCTS IMPLANTABLE PACING LEAD,TINED Oscor, Inc. DTB Class III 1982-12-03
K823447 IMPLANTABLE PACING LEAD, TINED #3262 & Vascular Products, Inc. DTB Class III 1982-12-03
K823448 IMPLANTABLE PACING LEAD TINED #3390 & Oscor, Inc. DTB Class III 1982-12-03
K823356 READY-BOX BODY-TEMP MEDIA WARMER MALLIN- Forma Scientific, Inc. DXT Class II 1982-12-03
K822781 MEDTRONIC MODELS 4011 & 4511 Medtronic Vascular DTB Class III 1982-11-30
K823434 MIKRO-TIP CATHETER PRESSURE TRANSDUCER Millar Instruments, Inc. DRF Class II 1982-11-30
K823433 BALLOON THERMODILUTION CATHETER #7164& Critikon Company, LLC DYG Class II 1982-11-30
K823108 INTERSEPT PEDIACTRIC EXTRACORPOREAL FILT Extracorporeal Medical Specialities, Inc. DTM Class II 1982-11-30
K823052 THE 500 MONITOR SERIES Vitatek DXN Class II 1982-11-30
K823312 CADIO-RESPIRATORY MONITOR #CR-2 Electromed Intl., Ltd. DRT Class II 1982-11-30
K822102 PRESS-O-TEST Medi-Swiss Corp. DXN Class II 1982-11-24
K822983 MINGOCARD 7 & MINGOPHONE 7 Siemens Corp. DSF Class I 1982-11-24
K823205 EXV VENOUS RESERVOIR BAG & HOLDER Extracorporeal Medical Specialities, Inc. DTN Class II 1982-11-24
K823125 CAPIOX II Terumo Medical Corp. DTZ Class II 1982-11-24
K822704 MODEL 366-07 ADAPT AID LEAD ADAPTER Intermedics, Inc. DTD Class II 1982-11-24
K823260 INTERFACE CARDIOTOMY BLOOD FILTER #51 Medical, Inc. JOD Class II 1982-11-24
K823220 COSMOS Nihon Kohden America, Inc. DPS Class II 1982-11-24
K823258 INTERFACE ARTERIAL BLOOD FILTER #40 Medical, Inc. DTM Class II 1982-11-24
K823215 CKG 8800 Cardio Kinetics, Inc. DSB Class II 1982-11-24
K823249 LIFESCOPE II/FOUR Nihon Kohden America, Inc. DRG Class II 1982-11-24
K823259 INTERFACE CARDIOTOMY BLOOD FILTER #50 Medical, Inc. JOD Class II 1982-11-24
K823210 MODEL 525 NEO-TRAK NEONATAL RECORDER Ge Medical Systems Information Technologies DSF Class I 1982-11-24
K822829 ROTARY VASCULAR KNIFE Medco Products, Co., Inc. DWS Class I 1982-11-17
K822970 HOLTER RECORDER Agilent Technologies DSH Class II 1982-11-03
K822806 BALLOON WEDGE PRESSURE, ANGIOGRAPHIC Nova Medical Specialties DYG Class II 1982-11-01
K823007 OPTICATH HEPARIN COATED, FLOW-DIRECT Oximetrix, Inc. DYG Class II 1982-11-01
K822750 MEDI-TRACE 5' OFFSET ELECTRODE Graphic Controls Corp. DRX Class II 1982-11-01
K822972 IL 801 THERMALDILUTION CARDIAC OUTPUT Instrumentation Laboratory CO DXG Class II 1982-11-01
K822955 MODEL 4242 TELE SYST ARRHYTHMIA MONITOR Medtronic Vascular DXH Class II 1982-11-01
K822803 BLOOD OXYGENATORS #BOS-105S BOS-5S W/ Bentley Laboratories, Inc. DTZ Class II 1982-11-01
K822952 560 Kone Instruments, Inc. DRT Class II 1982-11-01
K822834 ACCESS PERCUTANEOUS INTRODUCER SET Access Devices, Inc. DYB Class II 1982-11-01
K822432 CENTURION CHART RECORDER Clinical Data, Inc. DSF Class I 1982-11-01
K822961 PORTA FIB III Narco Scientific LDD Class II 1982-11-01
K822055 CNIBP BLOOD PRESSURE MEASUREMENT SYS Ohio Medical Products DXN Class II 1982-11-01
K822903 AUTOECHO Oxford Medilog, Inc. DXG Class II 1982-11-01
K822907 KALOS-03 BIPOLAR Biotronik Sales, Inc. DXY Class III 1982-11-01
K822909 PULSE OXIMETER MODEL 100 Nellcor, Inc. DQA Class II 1982-11-01
K821477 WM. HARVEY H-1300 INFANT/PEDIATRIC BLOOD C.R. Bard, Inc. DTZ Class II 1982-11-01
K820729 SARNS PULSATILE PUMP 3M Health Care, Sarns DWB Class II 1982-11-01
K822393 INTRAOPERATIVE BALLOON DILATION CATH. Advanced Cardiovascular Systems, Inc. DQY Class II 1982-11-01

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