meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
41
Latest Decision
1986-07-11

Clearances · page 157 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K862409 SNAP-ON TORQUER Advanced Cardiovascular Systems, Inc. DQX Class II 1986-07-11
K862298 ALTERNATE SIZE E-Z-PACE ELECTRODE Medtronic Vascular DRO Class II 1986-07-11
K862443 MEDTRONIC TEMPORARY AND IMPLANTABLE PACING LEADS Medtronic Vascular DTB Class III 1986-07-10
K861236 ACS CORONARY GUIDING CATHETER Advanced Cardiovascular Systems, Inc. DQO Class II 1986-07-10
K862258 MODEL 437-01 BIOPORE IMPLANTABLE PACING LEAD Intermedics, Inc. DTB Class III 1986-07-10
K862259 MODEL 433-01 BIOPORE IMPLANTABLE PACING LEAD Intermedics, Inc. DTB Class III 1986-07-10
K861828 CURITY VENOUS CATHETERIZATION KIT The Kendal Co. DQY Class II 1986-07-10
K862257 MODEL 431-02 BIOPORE IMPLANTABLE PACING LEAD Intermedics, Inc. DTB Class III 1986-07-10
K861829 CURITY CENTRAL VENOUS CATHETER The Kendal Co. DQY Class II 1986-07-10
K861710 MODEL UST-SSD 880L1-5 TRANESOPHAGEAL PHASED ARRAY Johnson & Johnson Professionals, Inc. DXK Class II 1986-07-09
K861378 ULTRAMED TF 122 ULTRASON VASCU IMAG & DOPPLER SYST Ultramed, Inc. JOP Class II 1986-07-07
K862052 MODEL 438-01 CARDIFIX IMPLANTABLE PACING LEAD Intermedics, Inc. DTB Class III 1986-07-03
K860867 DIGITAL SUBTRACTION ANGIOGRAPHY CATHETERS AND SETS Medical Components, Inc. DQO Class II 1986-07-02
K862276 MODEL 435-02 CARDIFIX IMPLANTABLE PACING LEAD Intermedics, Inc. DTB Class III 1986-07-02
K861158 S&W TYPE 888 ELECTRODE National Medical Technology DRX Class II 1986-07-01
K861719 MODIFIED MODELS 8320/8322/8329/8316/8317/8318 Medtronic Vascular DXY Class III 1986-07-01
K860634 PANASONIC BLOOD PRESSURE METER, ZH-852AP, ZH-858PP Panasonic Co. Div. Matsu Elec. Corp. America DXN Class II 1986-07-01
K862375 CARDIO PORT 500 24-H ECG AMBULATORY MONITOR SYSTEM Grandcor Medical Systems DSI Class II 1986-07-01
K860579 CARDIOSCAN DOPPLER OPTION Interspec, Inc. JOP Class II 1986-06-30
K862006 STAND & HIGH FLOW FEMORAL-VENTRICULAR PIGTAIL CATH Cordis Corp. DQO Class II 1986-06-27
K861403 TB SERIES BIPOLAR PACING LEADS Oscor Medical Corp. LDF Class II 1986-06-27
K860846 CORDIS HI-FLEX PERVENOUS BIPOLAR LEAD Cordis Corp. DTB Class III 1986-06-26
K861422 PACESETTER/SIEMENS PULSE GENERA W/VS-1 HEAD CAVITY Pacesetter Systems DXY Class III 1986-06-26
K860673 OXYGENATOR MODEL NOS. BENTLEY-10A & BENTLEY-10B American Bentley DTZ Class II 1986-06-26
K860239 ORG-7201 MULTIPARAMETER TELEMETRY MONITOR Nihon Kohden America, Inc. DRG Class II 1986-06-26
K861428 SUCTION CONTROL VALVE (NONADJUSTABLE) CAT.RLV-2100 American Omni Medical, Inc. DWD Class II 1986-06-26
K860136 BARD-PARKER CAROTID SHUNT Bd Becton Dickinson Vacutainer Systems Preanalytic DWF Class II 1986-06-25
K854963 S80 IMPLANTABLE CARDIAC PACING LEAD Sorin Biomedica, Fiat, USA, Inc. DTB Class III 1986-06-24
K861388 SARNS PORTABLE POWER MODULE 3M Health Care, Sarns DTQ Class II 1986-06-23
K854813 MEDNOVA BLOOD PRESSURE CUFF Mednova Corp. DXQ Class II 1986-06-20
K861951 MODIFIED TELEFLEX MEDICAL INTRODUCER CATHETER Teleflex, Inc. DYB Class II 1986-06-19
K862048 SUDS(HCG)CONTROL SET (URINE&SERUM) & HCG REF.SERUM Murex Corp. DQX Class II 1986-06-19
K862037 MODIFY LABEL/PASYS & MOD 8316/17/18 IMPLAN PUL GEN Medtronic Vascular DXY Class III 1986-06-17
K860681 DISPOSABLE FLUSH DEVICE Hewlett-Packard Co. DRS Class II 1986-06-17
K862071 MODIFIED LABEL FOR/SPECTRAX SXT IMPLANT. PULSE GEN Medtronic Vascular DXY Class III 1986-06-17
K862038 MODIFY LABEL/SPECTRAX S & SX IMPLANT PULSE GENER Medtronic Vascular DXY Class III 1986-06-17
K854493 ERG 555 COUCH ERGOMETER Robert Bosch Corp. DRT Class II 1986-06-16
K854492 ERG 551 ERGOMETER, BICYCLE Robert Bosch Corp. DRT Class II 1986-06-16
K854847 PHYSIO-DYNE ECG/HR 3 Physio-Dyne Industrument Corp. DRT Class II 1986-06-16
K861847 ACS ROTATING HEMO VALVE - DUAL ACCESS TYPE Advanced Cardiovascular Systems, Inc. LOX Class II 1986-06-16
K854491 ERG 550 ERGOMETER BICYCLE Robert Bosch Corp. DRT Class II 1986-06-16
K860547 MODEL 486-02 ENDOCARDIAL PACING LEAD Intermedics, Inc. DTB Class III 1986-06-13
K860548 MODEL 492-02 ENDOCARDIAL PACING LEAD Intermedics, Inc. DTB Class III 1986-06-13
K861607 SCHNEIDER-SHILEY INFLATION SYRINGES Shiley, Inc. MAV Class II 1986-06-09
K861606 SCHNEIDER-SHILEY WIRE TORQUER Shiley, Inc. DQX Class II 1986-06-09
K853561 LIFESTAT 100 Physio-Control Corp. DXN Class II 1986-06-09
K861992 MODEL 43200A CARDIAC MONITOR Hewlett-Packard Co. DPS Class II 1986-06-09
K854481 COLIN ELECTRONICS CO., LTD. STBP 680 Colin Medical Instruments Corp. DXN Class II 1986-06-09
K860584 SOFTWARE MODULE/2035 PROG AND ASTRA/T PULSE GEN Cardiac Pacemakers, Inc. KRG Class III 1986-06-06
K861924 MICRO ANASTOMOSIS CLAMP Pilling Co. DXC Class II 1986-06-06
K861481 ENDOCARDIAL CARBON-TIP LEAD Pacesetter Systems DTB Class III 1986-06-06
K860051 MODEL 8604 OXYGEN/PULSE MONITOR Nonin Medical, Inc. DQA Class II 1986-06-05
K861067 PARAGON 420, CARDIAC MONITOR Life Sensing Instrument Company, Inc. DPS Class II 1986-06-05
K860121 INTRAVASCULAR CATHETER W/DOPPLER TRANSDUCER NuMED, Inc. DPT Class II 1986-06-02
K861277 CRITICHEM CONTINUOUS BLOOD GAS MONTITOR, CVGM-1000 Critichem, Inc. DRY Class II 1986-06-02
K853953 CARDIOCAP MONITOR Instrumentarium Corp. DRT Class II 1986-06-02
K854856 THERMORITE MODEL HC-83 HYPO/HYPERTHERMIA UNIT Thermorite, Inc. DWJ Class II 1986-06-02
K854942 HORIZON 2000 NON-INVASIVE BLOOD PRESSURE CAP. Mennen Medical, Inc. DXN Class II 1986-06-02
K861226 INTERFACE CRYSTALLOID CARDIOPLEGIC FILTER MODEL 70 Medical, Inc. KRJ Class II 1986-06-02
K860076 GAMBRO ULTRASONIC BLOOD LEVEL DETECTOR ULD 10-200 Gambro, Inc. DTW Class II 1986-05-30
K861322 RMI POROUS VENT PLUG Research Medical, Inc. DWF Class II 1986-05-30
K861765 ACS WHOLEY HI-TORQUE GUIDE WIRE Advanced Cardiovascular Systems, Inc. DQX Class II 1986-05-30
K861310 STOCKERT-SHILEY AORTIC ROOT CANNULAE Shiley, Inc. DWF Class II 1986-05-30
K860702 SARNS FILTERED CARDIOTOMY RESERVOIR 3M Health Care, Sarns DTP Class II 1986-05-28
K860573 IMPLANT PROG PULSE GENERATOR, UNIPOLAR & BIPOLAR Telectronics, Inc. DXY Class III 1986-05-28
K861574 ACS HI-TORQUE TAPERED DIAMETER GUIDE WIRE Advanced Cardiovascular Systems, Inc. DQX Class II 1986-05-28
K861102 CPS-3000 CARDIOPLEGIA RESERVOIR Gish Biomedical, Inc. DTR Class II 1986-05-28
K860775 MEDIASTINAL AUTOTRANSFUSION SYSTEM Cardio Metrics, Inc. DTP Class II 1986-05-28
K861103 CHEST DRAINAGE PACK, CDP-1000 Gish Biomedical, Inc. DWF Class II 1986-05-28
K861177 CAPIOX III CARDIOPULMONARY BYPASS OXYGENATOR Terumo Medical Corp. DTZ Class II 1986-05-28
K860743 CAROTID BYPASS SHUNT WITH SAMPLING ARM Clincal Instruments Corp. DWF Class II 1986-05-28
K860742 CAROTID BYPASS SHUNT Clincal Instruments Corp. DWF Class II 1986-05-28
K860497 CAROTID BALLOON SHUNT Imodex, Inc. DWF Class II 1986-05-28
K861116 TORAY ANTHRON BYPASS TUBES Toray Industries (America), Inc. DWF Class II 1986-05-28
K861605 SCHNEIDER-SHILEY PRESSURE MANOMETER Shiley, Inc. KRK Class II 1986-05-28
K861496 STOCKERT-SHILEY VENOUS CATH & AORTIC ARCH CANNULA Shiley, Inc. DWF Class II 1986-05-27
K860988 RMI CAROTID BY-PASS SHUNT Research Medical, Inc. DWF Class II 1986-05-21
K861096 CARDIOPULMONARY CANNULA TUBING Bio Medicus, Inc. DWF Class II 1986-05-21
K860980 PC ARRHYTHMIA DETECTION/ANALYSIS - ARRHYTHMIA III Spacelabs, Inc. DSI Class II 1986-05-21
K860920 STOCKERT-SHILEY HEATER/COOLER TEMPERATURE CONTROL Shiley, Inc. DTR Class II 1986-05-21
K861437 QMED SYSTEM 2150 Qmed, Inc. DXG Class II 1986-05-20
K860307 PEEL AWAY & SPLIT SHEATH PERCU CATH INTRODUCER SET Teleflex, Inc. DYB Class II 1986-05-20
K860258 TELEFLEX TEFLON COATED GUIDEWIRE Teleflexmedical, Inc. DQX Class II 1986-05-20
K861464 LEAD BODY CHANGES TO HI PERFORM & FAST-PASS LEADS Pacesetter Systems DTB Class III 1986-05-19
K855045 MODEL 535 NEO-TRAK RECORDER Ge Medical Systems Information Technologies DSF Class I 1986-05-16
K855027 PULSE OXIMETER Physio-Control Corp. DQA Class II 1986-05-16
K854434 DINAMAP VITAL SIGNS MONITOR MODEL 8100 Critikon Company, LLC DXN Class II 1986-05-16
K861359 CARDIAC MONITOR, CARDIOTACHOMETER AND ALARM Hewlett-Packard Co. DPS Class II 1986-05-16
K861483 ANGIOGRAPHIC CATHETER (CARDIOLOGY & RADIOLOGY) Mallinckrodt Critical Care DQO Class II 1986-05-15
K854772 TRANSCOR (TM) RADIO-STETHOSCOPE K & S Medicorp DQD Class II 1986-05-13
K861745 VICKERS ERGOMATIC MICROSURG INSTRU CARDIAC SET Keeler Instruments, Inc. DWS Class I 1986-05-13
K861440 LEADS UTILIZ VOLUN STAND #1 3.2 MM UNI/BIOPOLAR CO Pacesetter Systems DTB Class III 1986-05-13
K860196 OSCILLOMATE NEONATAL BLOOD PRESS. MONIT.-MODEL 901 Cas Medical Systems, Inc. DXN Class II 1986-05-12
K860636 FASTRACE III, ECG ELECTRODE Andover Medical, Inc. DPS Class II 1986-05-09
K855102 MONARK 869 ERGOMETER Equilibrated Bio Systems, Inc. DSP Class II 1986-05-09
K854597 VICKERS MEDICAL MODEL 271 HEART RATE MONITOR Vickers , Ltd. DRT Class II 1986-05-09
K854797 TAKEDA MEDICAL DIGITAL SPHYGMOMANOMETER, UA-731 Takeda Medical, Inc. DXN Class II 1986-05-09
K854771 SALTZMAN STETHOSCOPE HEAD K & S Medicorp LDE Class I 1986-05-09
K861559 SERIES (T) PROGRAMMABLE CARDIAC PULSE GENERATORS Cook Pacemaker Corp. DXY Class III 1986-05-09
K860827 EM STRESS ELECTRODE Electromed Intl., Ltd. DRX Class II 1986-05-08

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