meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
48
Latest Decision
1993-03-08

Clearances · page 128 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K923221 KING OF HEARTS SCEPTER Instromedix, Inc. DPS Class II 1993-03-08
K920823 WELTER SNARE RETRIEVER Cook, Inc. DXE Class II 1993-03-04
K924575 ATLANTIS GUI Hospitronics MHX Class II 1993-03-04
K922552 MORSE(R) ANGIOGRAPHIC CATHETERS North American Instrument Corp. DQO Class II 1993-03-03
K921765 PRIMEDIC DEFIBRILLATORS-N/B Metronic Electronic GmbH LDD Class II 1993-03-03
K920445 SIEMENS SIRECUST PENTA SYSTEM AND ACCESSORIES Siemens Medical Electronics MHX Class II 1993-03-02
K925074 USCI LUMISILK GUIDE WIRE WITH PRO/PEL COATING C.R. Bard, Inc. DQX Class II 1993-03-01
K920871 J-LLOYD ARTERIAL EMBOLECTOMY CATHETER J-Lloyd Medical, Inc. DXE Class II 1993-02-26
K924562 CATHETER INTRODUCER Luther Medical Products, Inc. DYB Class II 1993-02-25
K922009 DISPOSABLE SURGICAL EXTENSION CABLE MODEL S-101 Remington Medical, Inc. DSA Class II 1993-02-25
K925411 MODEL 2041-PC/ST CARDIAC TELEMETRY MONITOR Accucore, Inc. DSI Class II 1993-02-25
K923054 WITT BIOMEDICAL SERIES II-EP Witt Biomedical Corporation MHX Class II 1993-02-25
K926172 SERIES 1500 DEFIBRILLATOR, MODIFICATION Marquette Electronics, Inc. MKJ Class III 1993-02-25
K923418 9293/1 INTERFACE MODULE S & W Medico Teknik DQA Class II 1993-02-23
K922060 .25' ULTRA-SELECT GUIDEWIRE Microvena Corp. DQX Class II 1993-02-23
K925809 COMPRESSAR UNIVERSAL (TM) SYSTEM Instromedix, Inc. DXC Class II 1993-02-22
K923117 CAVERNOSOMETRY MODULE FOR MENUET Dantec Medical, Inc. DXT Class II 1993-02-22
K926450 EDSLAB(R) DUAL LUMEN REGION SATUR OXIMETRY CATH Baxter Healthcare Corp DQE Class II 1993-02-22
K926250 ELECTROMEDICS EL-SERIES CARDIOTOMY RESERVOIR Electromedics, Inc. DTN Class II 1993-02-19
K924354 STOCKERT CAPS LOW LEVEL DETECT II/BUBBLE MONITOR Sorin Biomedica, Fiat, USA, Inc. DTW Class II 1993-02-18
K923558 ECG ELECTRODE Lectec Corp. DRX Class II 1993-02-18
K922027 AMBULATORY (HOLTER) RECORDING, MODIFICATION Biosensor Corp. DSI Class II 1993-02-17
K925542 OXYSHUTTLE II ,MODIFICATION Sensor Medics Corp. DQA Class II 1993-02-17
K924171 LEMAITRE RETROGRADE VALVULOTOME Vascutech, Inc. MGZ Class II 1993-02-16
K925804 SCHNEIDER HYDRO-SIL GUIDEWIRE Schneider Intl., Ltd. DQX Class II 1993-02-12
K922356 FLOW CONTROL VALVE, CAT. NO. ACV-38 American Omni Medical, Inc. MJJ Class II 1993-02-12
K923085 QUICKLAMP SYSTEM Disco, Inc. DXC Class II 1993-02-12
K922101 ANGIOGRAPHIC CATHETER -- MODIFICATION Interventional Therapeutics Corp. DQO Class II 1993-02-12
K925381 ACS HI-TORQUE BALANCE(TM) GUIDE WIRE Advanced Cardiovascular Systems, Inc. DQX Class II 1993-02-12
K923245 TRIGUIDE-PLUS GUIDING CATHETER Scimed Life Systems, Inc. DQY Class II 1993-02-12
K925833 CORDIS STEERABLE GUIDEWIRE Cordis Corp. DQX Class II 1993-02-12
K923915 TORQR SERIES DIAGNOSTIC EP CATHETERS Cardiorhythm DRF Class II 1993-02-10
K923343 HEWLETT-PACKARD MODEL M1020A PULSE OXIMETER Hewlett-Packard Co. DQA Class II 1993-02-10
K923916 VOYAGR SERIES DIAGNOSTIC EP CATHETERS Cardiorhythm DRF Class II 1993-02-10
K921638 SYSTEM 90 INTRA-AORTIC BALLOON PUMP CONSOLE Datascope Corp. DSP Class II 1993-02-10
K915554 HI-TORQUE SPORT-T(TM) GUIDE WIRE Peripheral Systems Group DQX Class II 1993-02-09
K914273 A&D TM-2421/2021 AMBULATORY BLOOD PRESSURE MONITOR A&D Engineering, Inc. DSK Class II 1993-02-09
K923638 ACESSORY PACK Medtronics Interventional Vascular LIT Class II 1993-02-08
K924075 DISPOSABLE OPTICAL VALVULOTOME Endovascular, Inc. MGZ Class II 1993-02-08
K925626 MAXIMA PLUS HOLLOW FIBER OXYGENATOR Medtronic Vascular DTZ Class II 1993-02-05
K911611 SYSTEM ATHENA, MODIFICATION S & W Medico Teknik DRT Class II 1993-02-05
K923696 CORDIS VIERA GUIDEWIRE Cordis Corp. DQX Class II 1993-02-03
K922368 PERIFLUX PF4001 LASER DOPPLER FLOWMETER Perimed, Inc. DPW Class II 1993-02-03
K925541 STOCKERT 1/4 BUBBLE SENSOR Sorin Biomedica, Fiat, USA, Inc. KRL Class II 1993-02-02
K922669 MULTIDOP MODEL HD-2020 BI-DIRECTIONAL BLOOD FLOW Koven and Assoc., Inc. DPW Class II 1993-01-29
K925535 CARDIOBEEPER(R) CB-IIA Survival Technology, Inc. DXH Class II 1993-01-28
K913940 RESPONSE(TM) STEERABLE CATHETER Daig Corp. DRA Class II 1993-01-26
K924054 PHONOCARDIOGRAPH Echo Ultrasound DQC Class I 1993-01-22
K920333 SMARTDOP 20 BI-DIRECTIONAL BLOOD FLOW DETECTOR Koven and Assoc., Inc. DPW Class II 1993-01-22
K925419 PASSAGE HEMOSTASIS VALVE Merit Medical Systems, Inc. DTL Class II 1993-01-22
K920822 CARDIOVASCULAR PERMANENT PACEMAKER ELECTRODE Siemens-Pacesetter, Inc. DTB Class III 1993-01-22
K922972 MODELS 438-05 AND 435-05 IMPLANTABLE PACING LEAD Intermedics, Inc. DTB Class III 1993-01-22
K923681 EXONOX PERCUTANEOUS INTRODUCER SYSTEM W/ HEMOSTASI Exonix Research Corp. DYB Class II 1993-01-21
K924116 MEDRAD MCT, MCT PLUS INJECTOR/MEDRAD FRONT LOAD Medrad, Inc. DXT Class II 1993-01-21
K920587 PHYSIOLOGICAL MEASUREMENT AND DISPLAY SYSTEMS Siemens Medical Solutions USA, Inc. DQK Class II 1993-01-15
K920873 WEDGE PRESSURE BALLOON CATHETER BY J-LLOYD J-Lloyd Medical, Inc. DQO Class II 1993-01-14
K920869 FLOW DIRECTED THERMODILUTION BALLOON CATHETER J-Lloyd Medical, Inc. DYG Class II 1993-01-13
K922970 INTRA-OPERATIVE TEC ATHERECTOMY SYSTEM Intensive Technology, Inc. MCW Class II 1993-01-13
K923518 GUIDING CATHETER Interventional Therapeutics Corp. DQY Class II 1993-01-12
K925352 CLEAN CUFF BLOOD PRESSURE CUFF LINER Steridyne Corp. DXQ Class II 1993-01-12
K922611 SCIMED 6 FR. TRIGUIDE - ELITE GUIDING CATHETER Scimed Life Systems, Inc. DQY Class II 1993-01-11
K920870 ANGIOGRAPHIC BALLOON CATHETER BY J LLOYD J-Lloyd Medical, Inc. DQO Class II 1993-01-07
K920580 TRANSDUCER, PRESSURE, CATHETER TIP Medamicus, Inc. DXO Class II 1993-01-07
K920082 BIOCHEM MODEL 3301 NEWOX1 OXIMETER Biochem International, Inc. DQA Class II 1993-01-07
K922783 ES1700 ECG MODULATOR Epic Systems, Inc. DXH Class II 1993-01-07
K923367 COSGROVE EDWARDS ANNULOPLASTY SYSTEM, MODEL 4600 Baxter Healthcare Corp KRH Class II 1993-01-06
K922787 ECHOMARK GUIDEWIRE WITH ULTRASONIC LOCALIZATION Echocath, Inc. DQX Class II 1993-01-06
K921343 COBE PATIENT MONITORING PRODUCTS Cobe Cardiovascular, Inc. DRS Class II 1993-01-05
K921608 PRESSSION, SEQUENTIAL Chattanooga Group, Inc. JOW Class II 1992-12-30
K921487 MARQUETTE SERIES 360 DEFIBRILLATOR Marquette Electronics, Inc. LDD Class II 1992-12-29
K915073 MARQUETTE SV O2 MODULE Marquette Electronics, Inc. DQE Class II 1992-12-29
K922171 CENTRA II ANALYSIS SYSTEM Marquette Electronics, Inc. DQK Class II 1992-12-28
K920778 OMRON WRIST DIGITAL BLOOD PRESSURE MONITOR HEM-601 Omron Healthcare, Inc. DXN Class II 1992-12-24
K915573 VENOUS RESERVOIR W/CARDIOTOMY FILTER Baxter Healthcare Corp DTN Class II 1992-12-23
K914823 OMRON OSCILLOMETRIC DIGIT BLOOD PRES MONIT-HEM-706 Omron Healthcare, Inc. DXN Class II 1992-12-23
K910811 SENSOR SHIELD Medical Taping Systems, Inc. DQA Class II 1992-12-23
K922899 MODEL 4280 SURGICAL EXTENSION CABLE Pace Medical DSA Class II 1992-12-23
K923699 DIAGNOSTIC INTRAVASCULAR CATHETER Applied Vascular DQO Class II 1992-12-21
K922674 NAVIGUIDE HYDROPHILIC COATED GUIDEWIRE Meadox Medicals, Div. Boston Scientific Corp. DQX Class II 1992-12-21
K920891 ROADRUNNER(TM) WIRE GUIDE, MODIFICATION Cook, Inc. DQX Class II 1992-12-21
K920936 RMI EXTERNAL CORONARY ARTERY OCCLUDER Research Medical, Inc. DXC Class II 1992-12-18
K920154 BSM-8800A BEDSIDE MONITOR Nihon Kohden America, Inc. DSI Class II 1992-12-18
K921699 ES 1500 ECG DEMODULATOR Epic Systems, Inc. DXH Class II 1992-12-17
K924672 ZYMED TELEMETRY MONITOR MODEL T8010 (PRELIMINARY) Agilent Technologies DSI Class II 1992-12-15
K915301 ADVANCE STOPCOCK/HIGH PRESSURE STOPCOCK Advance Medical Designs, Inc. DTL Class II 1992-12-11
K921920 SOFT-TEMP Adroit Medical Systems, Inc. DWJ Class II 1992-12-11
K920977 MERITRANS(TM) DISPOSABLE TRANSDUCER Merit Medical Systems, Inc. DRS Class II 1992-12-11
K922706 SCIMED SIDELINER Scimed DQX Class II 1992-12-10
K922536 TORQUE DEVICE Procedure Products, Inc. DQX Class II 1992-12-10
K915550 MINI DOPPLER II ULTRASOUND BLOOD FLOW DETECTOR Koven and Assoc., Inc. DPW Class II 1992-12-10
K924643 MEDTRONIC BIO-MEDICUS CANNULA INSERTION KIT Medtronic Bio-Medicus, Inc. DWF Class II 1992-12-08
K922541 USCI SUPER 9 PTCA GUIDING CATHETER C.R. Bard, Inc. DQI Class II 1992-12-08
K924987 TAPER GUIDEWIRES Target Therapeutics DQX Class II 1992-12-08
K924591 SCHNEIDER SOLID-7 SOPTIP GUIDING CATHETER Schneider Intl., Ltd. DQY Class II 1992-12-08
K924712 ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM Hearing Tech, Inc. MCW Class II 1992-12-08
K922218 IQ SYSTEM Renaissance Technology, Inc. DXG Class II 1992-12-08
K922573 10 AND 20 CC INFLATION/DEFLATION DEVICES W/GAUGE Boston Scientific Corp MAV Class II 1992-12-08
K915869 RMI NORMOCLUDER CORONARY ARTERY OCCLUDER Research Medical, Inc. MJN Class II 1992-12-08
K922974 PORTABLE PATIENT MONITOR Hewlett-Packard Co. MHX Class II 1992-12-07
K921254 BLUE MAX II BALLOON DDILATATION CATHETER Boston Scientific Corp LIT Class II 1992-12-03

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