meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
39
Latest Decision
1981-03-27

Clearances · page 180 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K810352 SWAN-GANZ FLOW-DIRECTED THERMODILUTION American Edwards Laboratories DYG Class II 1981-03-27
K810696 PHYSIOLOGIC RECORDER Honeywell, Inc. DPS Class II 1981-03-27
K810750 PDS CARDIAC CALC. SOFTW. PROGR. #A3604AE General Electric Co. DQK Class II 1981-03-27
K810675 ARROW RADIAL ARTERY CATHETERIZATION SET Arrow Intl., Inc. DQX Class II 1981-03-27
K810661 CATHDAMP Medline Industries, Inc. DRS Class II 1981-03-27
K810730 MODEL SP5107 THERMODILUTION CATHETER Gould, Inc. KRB Class II 1981-03-27
K803270 GANZ CORONARY REPERFUSION CATHETER American Edwards Laboratories DQO Class II 1981-03-27
K810731 MODEL IM1000 INTEGRATED MONITOR Gould, Inc. DQK Class II 1981-03-27
K810027 DATAMEDIX PECGASYS SYSTEM Datamedix DSI Class II 1981-03-26
K810154 LIFEPAK 7 ACUTE CARDIAC CARE SYSTEM Physio-Control Corp. DPS Class II 1981-03-26
K810331 DUO-TEL General Electric Co. DRG Class II 1981-03-20
K810493 TYPE N ENDOCARDIAL LEAD Biotronik Sales, Inc. DTB Class III 1981-03-20
K810492 TYPE YR ENDOCARDIAL LEAD Biotronik Sales, Inc. DTB Class III 1981-03-20
K810552 CORDIS PACEMAKER PROGRAMMERS 255A & 256A Cordis Corp. KRG Class III 1981-03-20
K810491 TYPE YC ENDOCARDIAL LEAD Biotronik Sales, Inc. DTB Class III 1981-03-20
K810548 CARDIOPULMINARY BYPASS CATHETER CANNULA Dlp, Inc. DWF Class II 1981-03-17
K803286 CARDIOMEMO Instromedix, Inc. KRE Class II 1981-03-17
K810415 SARNS TWO-STATE WIRE REINFORCED CATHETER 3M Health Care, Sarns DWF Class II 1981-03-17
K810563 QUINTON LTE ELECTRODE Quinton, Inc. DRX Class II 1981-03-17
K810386 THINLITH II PULSE GNEERATOR MODEL 227-05 Intermedics, Inc. DXY Class III 1981-03-13
K810333 TEMPORARY MYOCARDIAL PACING LEAD#6400 Medtronic Vascular DTB Class III 1981-03-13
K810582 ELECTRODE, PACEMAKER PERMANENT Pacesetter Systems DTB Class III 1981-03-13
K810432 CORDIS PERVENOUS ATRIAL LEAD Cordis Corp. DTB Class III 1981-03-13
K810461 BURRON CENTRAL VEIN CATHERIZATION KIT Burron Medical Products, Inc. DQY Class II 1981-03-11
K810431 NARCO TLECARE MINIATURE PRESSURE DOME Narco Bio-Systems DRS Class II 1981-03-11
K810460 BURRON PERCUTANEOUS INDUCER SET Burron Medical Products, Inc. DQY Class II 1981-03-11
K810360 BAIM TM CORONARY SINUS FLOW THERMAL Electro-Catheter Corp. DQO Class II 1981-03-11
K802924 KONTRON PERCUTAEOUS DOUBLE-LUMEN Avco Medical Products DSP Class II 1981-03-11
K810357 STRESS TEST SYSTEM Nihon Kohden America, Inc. DPS Class II 1981-03-11
K802900 HEART SENTINEL Totemite Medical Electronics DSI Class II 1981-03-11
K801903 SERIES 4000 STRESS & EXERCISE SYSTEM Instruments For Cardiac Research DSI Class II 1981-03-11
K803179 DISPOSABLE ELECTRODE FOR EKG Midwest Monitoring DRX Class II 1981-03-11
K802890 CPS-1000 Gics Pharmaceuticals DTN Class II 1981-03-05
K810410 STERILE PACKAGING Telectronics, Inc. DXY Class III 1981-03-05
K810412 USCI CARDIOVASCULAR CATHETER C.R. Bard, Inc. DQO Class II 1981-03-05
K810395 PRE-BYPASS FILTER Texas Medical Products, Inc. KRJ Class II 1981-03-05
K810376 MEADOX SZILAGYI GRAFT Meadox Medicals, Div. Boston Scientific Corp. DSY Class II 1981-03-05
K810163 AM 420 MICROPROCESSOR Honeywell, Inc. DXG Class II 1981-03-05
K810312 ELECATH DUAL MODE TRANSTHORACIC PACING Electro-Catheter Corp. LDF Class II 1981-03-04
K810245 IMPLANTABLE PACEMAKER LEAD ADAPTER Intermedics, Inc. DTD Class II 1981-03-04
K802368 OPTION 301 PACEMAKER EVAL. MODULE MAC-1 Marquette Electronics, Inc. DPS Class II 1981-03-04
K810363 EAR OXIMETER Bio-Tek Instruments, Inc. DPZ Class II 1981-02-27
K803282 GUARDIAN MONITOR (CARDIOVASCULAR) Bd Becton Dickinson Vacutainer Systems Preanalytic DSI Class II 1981-02-27
K810178 PATIENT MONITOR CM111, 112 Honeywell, Inc. DSK Class II 1981-02-25
K810172 PRESSURE FUNCTION BLOCKS Honeywell, Inc. DSK Class II 1981-02-25
K810164 VC 430 VIDEO CONVERTER Honeywell, Inc. DXJ Class II 1981-02-25
K810170 TREND GRAPH FUNCTION BLOCK Honeywell, Inc. DXG Class II 1981-02-25
K810176 ECG FUNCTION BLOCK Honeywell, Inc. DPS Class II 1981-02-25
K810167 SINGLE CHANNELL RECORDER AR110 Honeywell, Inc. DSF Class I 1981-02-25
K810169 CENTRAL STATION CONTROLLER AC100/CE100 Honeywell, Inc. DSF Class I 1981-02-25
K810171 PERIPHERAL PULSE FUNCTION BLOCKS Honeywell, Inc. DSK Class II 1981-02-25
K810177 PATIENT MONITOR MODEL CM130, 140 Honeywell, Inc. DXG Class II 1981-02-25
K810166 1,2,3 CHANNELL RECORDERS (AR150,AR250,-) Honeywell, Inc. DSF Class I 1981-02-25
K810168 SLAVE MONITORS DC109 & VS109 Honeywell, Inc. DXJ Class II 1981-02-25
K810179 DUAL TRACE PATIENT MONITOR 116,118,120 Honeywell, Inc. DSK Class II 1981-02-25
K810165 DUAL TRACE VIDEO MONITOR VM 410 Honeywell, Inc. DXJ Class II 1981-02-25
K810121 UNIFOCAL 3 American Pacemaker Corp. DXY Class III 1981-02-23
K803313 PACING SYSTEM ANALYZER Medtronic Vascular DTE Class II 1981-02-23
K810009 DISPOSABLE DIAPHRAGM DOME Medex, Inc. DRS Class II 1981-02-19
K810237 PORTABLE, BATTERY OPERATED DEFIBRILLATOR Honeywell, Inc. LDD Class II 1981-02-19
K810263 MICROPROCESSOR CONTROLLED ELECTROCARDIO Honeywell, Inc. DPS Class II 1981-02-19
K802357 TELEMETRY PACEMAKER MONITOR Intermedics, Inc. DRG Class II 1981-02-12
K801584 MULTI-PROGRAMMABLE PACEMAKER & PROGRMR. Medtronic Vascular DXY Class III 1981-02-12
K802295 POLY FLEX IMPLANTABLE PACING LEAD Intermedics, Inc. DTB Class III 1981-02-09
K801810 PACEMAKER PATIENT MGMT. SYSTEM Siemens Elema AB DQK Class II 1981-02-05
K802864 SIEMENS-ELEMA PULSE GENERATOR 678 Siemens Elema AB DXY Class III 1981-02-05
K810041 CORDIS TEMPORATY CURVED ATRIAL LEAD Cordis Corp. LDF Class II 1981-02-05
K810202 CORDIS MULTIFILAR PERVENOUS VENTRIC. LD Cordis Corp. DTB Class III 1981-02-05
K803037 WILLIAM HARVEY VENTED MEDIASTINAL DRAIN C.R. Bard, Inc. DWM Class II 1981-02-04
K810162 FOGARTY SOFTJAW 6MM SPRING CLIP, #614-06 American Edwards Laboratories DXC Class II 1981-02-04
K810124 SWAN-GANZ VIP THERMODILUTION CATHETER American Edwards Laboratories DYG Class II 1981-02-04
K803000 IONESCU-SHILEY AORTIC GRAFT VALVE Shiley, Inc. DSY Class II 1981-02-02
K810079 SARNS INTEGRATED CARDIOPLEGIA DELIV. SYS 3M Health Care, Sarns KRI Class I 1981-01-30
K810102 INFANT ECG ELECTRODE #60-1029 Aspen Laboratories, Inc. DRX Class II 1981-01-29
K810104 ECG ARRHYTHMIA STIMULATOR Belmont Instrument Corp. DPS Class II 1981-01-29
K810036 SIEMENS-ELEMA MYOCARDIAL LEAD Siemens Elema AB DXY Class III 1981-01-29
K810103 ADULT ECG ELECTRODE #60-0724 Aspen Laboratories, Inc. DRX Class II 1981-01-29
K802113 SIRECUST 400 SYSTEM PATIENT MONITORING Analogic Corp. DPS Class II 1981-01-22
K810068 PEDIATRIC ARTERIAL BLOOD FILTER Delta Medical Industries DTM Class II 1981-01-22
K803315 CRITERION II RHYTHM PROFILE MONITOR Dart Medical Equipment DXH Class II 1981-01-22
K802717 HP MODEL 4710A ECG TRANSMITTER Hewlett-Packard Co. DXH Class II 1981-01-22
K802970 TERUMO HOLLOW FIBER OXYGENATOR Terumo America, Inc. DTZ Class II 1981-01-22
K803197 IMPL. PROGRAMMABLE BIPOLAR CARD.GEN.#274 Telectronics, Inc. DXY Class III 1981-01-22
K803003 INTERPULSE MEMBRANE OXYGENATION SYSTEM Extracorporeal Medical Specialities, Inc. DTZ Class II 1981-01-22
K802545 CARDIOPLEGIC SETS Texas Medical Products, Inc. DTR Class II 1981-01-16
K803231 THB 6000 HARDSHELL BUBBLE OXYGENATOR Travenol Laboratories, S.A. DTZ Class II 1981-01-16
K802917 MARK III ULTRASONIC SCANNING SYSTEM Advanced Technology Laboratories, Inc. DXK Class II 1981-01-16
K803309 VITASTAT ECG-1/ECG-3 ELECTROCARDIOGRAPH Advanced Technology Laboratories, Inc. DPS Class II 1981-01-16
K802816 ENDOCARDIAL LEADS 414S & 515S Siemens Elema AB DTB Class III 1981-01-16
K802539 DISPOSABLE GAS LINE FILTER Texas Medical Products, Inc. KRI Class I 1981-01-16
K802543 RIDGID VENA CAVA CANNULAE Texas Medical Products, Inc. DWF Class II 1981-01-16
K802541 DISPOSABLE PARALLEL Y CONNECTORS Texas Medical Products, Inc. KRI Class I 1981-01-16
K802552 PERM. ENDOCARDIAL UNIPOLAR TINED/WEDGE Daig Corp. DTB Class III 1981-01-16
K803058 SWAN-GANZ FLOW-DIRECTED MULTIPUR. CATH. American Edwards Laboratories LDF Class II 1981-01-16
K802547 PERMANENT & TEMP. PACEMAKER ELECTRODE Daig Corp. DTB Class III 1981-01-16
K810008 ALP-KII Martin'S Maine Exchange DXQ Class II 1981-01-16
K802544 DISPOSABLE QUICK RELEASE PERFUSION ADAP Texas Medical Products, Inc. DTL Class II 1981-01-16
K802553 PERM. ENDOCARDIAL UNIPOLAR WEDGE URETHAN Daig Corp. DTB Class III 1981-01-16
K802542 DISPOSABLE CONNECTORS Texas Medical Products, Inc. KRI Class I 1981-01-16
K803123 CRT DISPLAY #1310B Hewlett-Packard Co. DXJ Class II 1981-01-13

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