Anesthesiology
Review Panel
- CardiovascularReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart D—Cardiovascular Prosthetic DevicesCFR Sub-Part
- Subpart E—Cardiovascular Surgical DevicesCFR Sub-Part
- BYSOxygenator, Long Term Support Greater Than 6 Hours2Product Code
- DRYMonitor, Blood-Gas, On-Line, Cardiopulmonary Bypass2Product Code
- DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass2Product Code
- DTMFilter, Blood, Cardiopulmonary Bypass, Arterial Line2Product Code
- DTNReservoir, Blood, Cardiopulmonary Bypass2Product Code
- DTPDefoamer, Cardiopulmonary Bypass2Product Code
- DTQConsole, Heart-Lung Machine, Cardiopulmonary Bypass2Product Code
- DTRHeat-Exchanger, Cardiopulmonary Bypass2Product Code
- K240190MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System Uncoated2Cleared 510(K)
- K223879Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M)2Cleared 510(K)
- K220110Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat Exchanger2Cleared 510(K)
- K212688Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat Exchanger2Cleared 510(K)
- K201984MPS 3 ND Myocardial Protection System2Cleared 510(K)
- K200438MPS 3 Myocardial Protection System2Cleared 510(K)
- K173716MPS2 Myocardial Protection System Console2Cleared 510(K)
- K162774MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface (Bridge System)2Cleared 510(K)
- K162958MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface; MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface with Bridge; MYOtherm XP Cardioplegia Delivery System; MYOtherm XP Cardioplegia Delivery System with Bridge2Cleared 510(K)
- K090555PLEGIOX CARDIOPLEGIA HEAT EXCHANGER WITH SOFTLINE COATING, MODEL BIO-CHX 302Cleared 510(K)
- K081838GISH VISION BLOOD CARDIOPLEGIA WITH HA COATING2Cleared 510(K)
- K072583PLEGIOX CARDIOPLEGIA HEAT EXCHANGER, WITH SAFELINE COATING, MODEL(S) CHX30, BSQ-CHX 302Cleared 510(K)
- K041979MPS MYOCARDIAL PROTECTION SYSTEM - MPS 2 CONSOLE, MODEL 52012602Cleared 510(K)
- K040355VISION BLOOD CARDIOPLEGIA SYSTEM AND EXTRACORPORAL HEAT EXCHANGER WITH GBS COATING2Cleared 510(K)
- K032068CARDIOVENTION CORX IOS-200 SYSTEM, MODEL IOS-2002Cleared 510(K)
- K021830SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOPLEGIA SYSTEM2Cleared 510(K)
- K020106VISION BLOOD CARDIOPLEGIA SYSTEM AND EXTRACORPOREAL HEAT EXCHANGER2Cleared 510(K)
- K012898MODIFICATION TO: CSC14 BLOOD CARDIOPLEGIA SYSTEM2Cleared 510(K)
- K000977COMPONENTS FOR CARDIOVASCULAR PROCEDURE KIT - HEAT EXCHANGER COILS2Cleared 510(K)
- K003724CBMYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM WITH CARMEDA BIOACTIVE SURFACE, MODELS CB41 AND CB41-B2Cleared 510(K)
- K991137ENGUARD PHX CARDIOPLEGIA HEAT EXCHANGER2Cleared 510(K)
- K982467CAPIOX CARDIOPLEGIA2Cleared 510(K)
- K973475CARMEDA COATED CARDIOTHERM BLOOD CARDIOPLEGIA SYSTEMS (CBCTXXX SERIES AND CBCTXXXBR SERIES)2Cleared 510(K)
- K964571VISION CARDIOPLEGIA DELIVERY SYSTEM2Cleared 510(K)
- K962320S3 CARDIOPLEGIA CONTROL2Cleared 510(K)
- K953838MYOCARDIAL PROTECTION SYSTEM2Cleared 510(K)
- K944219SINGLE PASS BLOOD CARDIOPLEGIA SPBC SYSTEM COMPONENTS2Cleared 510(K)
- K944267HEAT EXCHANGER MODIFICATION FOR DUO AND OPTIMA2Cleared 510(K)
- K934355ELECTROMEDICS BLOOD HEAT EXCHANGER2Cleared 510(K)
- K932251ROTATOR;MALE-MALE, MALE-FEMALE2Cleared 510(K)
- K931967HE-30 GOLD2Cleared 510(K)
- K925369BCD ADVANCED BLOOD CARIOPLEGIA SYSTEMS2Cleared 510(K)
- K923311CONDUCER HEAT EXCHANGER2Cleared 510(K)
- K913077LANCASTER COOLING JACKET, CAT. CODE #13500/135012Cleared 510(K)
- K913691CPS-PLUS CARDIOPLEGIA SYSTEMS, CAT# CPS-X SERIES2Cleared 510(K)
- K914742MYOCARD PROTECT SYST W/BLOOD CARDIO HEAT EXC/MODIF2Cleared 510(K)
- K905500MYOCARDIAL PROTECTION SYSTEM2Cleared 510(K)
- K910923BCD ADVANCED2Cleared 510(K)
- K905568TOPICAL COOLING PAD, MODEL 70002Cleared 510(K)
- K904171SCIMED CARDIOTHERM CARDIOPLEGIA DELIVERY SYSTEM2Cleared 510(K)
- K896807SPBC SERIES SINGLE PASS BLOOD CARDIOPLEGIA SYSTEM2Cleared 510(K)
- K896020EXTRACORPOREAL HEAT EXCHANGER HE SERIES2Cleared 510(K)
- K900640MODIFIED MP-4 CARDIOPLEGIA DELIVERY SYSTEM W/CONDU2Cleared 510(K)
- K897039SARNS MINIPRIME CARDIOPLEGIA SET W/CONDUCER(TM)2Cleared 510(K)
- K884560SCIMED ECMOTHERM(TM) HEAT EXCHANGER2Cleared 510(K)
- K883071SARNS MP4 CARDIOPLEGIA DELIVERY SYSTEM2Cleared 510(K)
- K883439INTERSEPT*CRYSTALLOID CARDIOPLEGIA DELIVERY SYSTEM2Cleared 510(K)
- K883330BASIC HEATER-COOLER UNIT, 115/100V 16-02-202Cleared 510(K)
- K883331BASIC HEATER-COOLER UNIT W/MAST, 115/110V 16-21-102Cleared 510(K)
- K883332MAST FOR BASIC HEATER-COOLER UNIT 16-09-002Cleared 510(K)
- K880663SHILEY BCD PLUS HEAT EXCHANGER2Cleared 510(K)
- K880451SCIMED MODELS P-7-14 AND A-19-38 HEAT EXCHANGERS2Cleared 510(K)
- K873561ELECTROMEDICS D1079E2Cleared 510(K)
- K870804CARDIOPLEGIA HEAT EXCHANGER MODEL NO. HE-1002Cleared 510(K)
- K871774CCS-XXX, CARDIOPLEGIA ADMINISTRATION SETS2Cleared 510(K)
- K861102CPS-3000 CARDIOPLEGIA RESERVOIR2Cleared 510(K)
- K860920STOCKERT-SHILEY HEATER/COOLER TEMPERATURE CONTROL2Cleared 510(K)
- K860523CARDIO-COOL2Cleared 510(K)
- K853791NORTON CARDIOPLEGIC QUICK COOLING COIL 421738-0002Cleared 510(K)
- K853516SARNS RETROGRADE CARDIOPLEGIA DELIVERY SYSTEM2Cleared 510(K)
- K853410MODEL 492-03 POLYFLEX IMPLANTABLE PACING LEAD2Cleared 510(K)
- K852780BCD PLUS BLOOD CARDIOPLEGIA SYS(HEREAF REFER DEV)2Cleared 510(K)
- K850794PATIENT MONITOR MODEL RM-3002Cleared 510(K)
- K843983MYOCARDIAL INSULATOR2Cleared 510(K)
- K840256CARDIOPLEGIA HEAT EXCHANGER HOLDER2Cleared 510(K)
- K840045CARDIOPLEGIA HEAT EXCHANGER HE-1002Cleared 510(K)
- K833555LAL TEST RELEASE & BONCHEK CAR/JACKET2Cleared 510(K)
- K833662CARDIOPLEGIA SYSTEM CCS-XXX SERIES2Cleared 510(K)
- K832417HYPOTHERMIC MYCARDIAL PROTECTION DEV2Cleared 510(K)
- K831157BLOOD CARDIOPLEGIA STAINLESS STEEL COOL2Cleared 510(K)
- K823451CLEAR CARDIOPLEJIA DELIVERY SYSTEM2Cleared 510(K)
- K823533JACKET & SET2Cleared 510(K)
- K813264D6ZO DISPOSABLE HEAT EXCHANGER2Cleared 510(K)
- K812093COBE HEAT EXCHANGER RESERVOIR MODULE2Cleared 510(K)
- K811204BRONCHEK-SHILEY CARDIAC JACKET & BSC J2Cleared 510(K)
- K802545CARDIOPLEGIC SETS2Cleared 510(K)
- K802879BUCKBERG-SHILEY BLOOD CARDIOPLEGIC SPL.2Cleared 510(K)
- K802848CARDIOPLEGIA COOLING SYST. CCAS-22Cleared 510(K)
- K800717TOPICAL COOLING DEV. TCD. #27-9992Cleared 510(K)
- K800377CARDIOPLEGIA DELIVERY SYSTEM2Cleared 510(K)
- K791430MINIPRIME HYPOTHERMIC HEAT EXCHANGER2Cleared 510(K)
- K790756HEAT EXCHANGER COIL2Cleared 510(K)
- K781764PAD, COOLING #27-9992Cleared 510(K)
- K781210HEAT EXCHANGER, FHX-142Cleared 510(K)
- K772117HEAT EXCHANGER, DISP., OMNITHERM2Cleared 510(K)
- K770017PACING KIT, TRANSMYOCARDIAL2Cleared 510(K)
- K770018PACING KIT, SEMI-FLOATING2Cleared 510(K)
- K770016PACING KIT, ELECATH TRANSTHORACIC2Cleared 510(K)
- DTSSucker, Cardiotomy Return, Cardiopulmonary Bypass2Product Code
- DTWMonitor And/Or Control, Level Sensing, Cardiopulmonary Bypass2Product Code
- DTXGas Control Unit, Cardiopulmonary Bypass2Product Code
- DTYSensor, Blood-Gas, In-Line, Cardiopulmonary Bypass2Product Code
- DTZOxygenator, Cardiopulmonary Bypass2Product Code
- DWAControl, Pump Speed, Cardiopulmonary Bypass2Product Code
- DWBPump, Blood, Cardiopulmonary Bypass, Roller Type2Product Code
- DWCController, Temperature, Cardiopulmonary Bypass2Product Code
- DWDSuction Control, Intracardiac, Cardiopulmonary Bypass2Product Code
- DWETubing, Pump, Cardiopulmonary Bypass2Product Code
- DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass2Product Code
- DWPDilator, Vessel, Surgical2Product Code
- DWQStripper, Vein, External2Product Code
- DWSInstruments, Surgical, Cardiovascular1Product Code
- DWXStripper, Artery, Intraluminal2Product Code
- DWZDevice, Biopsy, Endomyocardial2Product Code
- DXCClamp, Vascular2Product Code
- DXSGauge, Pressure, Coronary, Cardiopulmonary Bypass2Product Code
- JODFilter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass2Product Code
- JORGenerator, Pulsatile Flow, Cardiopulmonary Bypass3Product Code
- KFMPump, Blood, Cardiopulmonary Bypass, Non-Roller Type2Product Code
- KRIAccessory Equipment, Cardiopulmonary Bypass1Product Code
- KRJFilter, Prebypass, Cardiopulmonary Bypass2Product Code
- KRLDetector, Bubble, Cardiopulmonary Bypass2Product Code
- LXNProbe, Test, Heart-Valve1Product Code
- MCWCatheter, Peripheral, Atherectomy2Product Code
- MFYEndothelial Cell Harvesting Kit2Product Code
- MGZValvulotome2Product Code
- MJJCpb Check Valve, Retrograde Flow, In-Line2Product Code
- MJNCatheter, Intravascular Occluding, Temporary2Product Code
- MNJValve, Pressure Relief, Cardiopulmonary Bypass2Product Code
- MWSStabilizer, Heart1Product Code
- NCPCannula, Arterial, Cardiopulmonary Bypass (Cpb), Embolism Protection2Product Code
- NLJStripper, Vein, External, Reprocessed2Product Code
- NMFClamp, Vascular, Reprocessed2Product Code
- NQGStabilizer, Heart, Non-Compression, Reprocessed1Product Code
- OETCardioplegia Solution Administration Kit2Product Code
- OEUCardiopulmonary Bypass Catheter Kit2Product Code
- OFACardiovascular Surgical Instruments Tray1Product Code
- OFGCt Biopsy Tray2Product Code
- PNQApical Closure Device2Product Code
- PYXTemporary Non-Roller Type Right Heart Support Blood Pump3Product Code
- PTNReservoir, Blood, Cardiopulmonary Bypass, Exempt2Product Code
- PZSDual Lumen Ecmo Cannula2Product Code
- QJZExtracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure2Product Code
- QNRBlood Pump For Ecmo, Long-Term (> 6 Hours) Use2Product Code
- QOHExtracorporeal System For Carbon Dioxide Removal2Product Code
- QHWSingle Lumen Ecmo Cannula2Product Code
- QTFReprocessed Atherectomy Catheter2Product Code
- QWFTubing, Long Term Support Greater Than 6 Hours2Product Code
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Cardiovascular Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
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- OphthalmicReview Panel
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- PathologyReview Panel
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- UnknownReview Panel
SINGLE PASS BLOOD CARDIOPLEGIA SPBC SYSTEM COMPONENTS
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K944219
- 510(k) Type
- Traditional
- Applicant
- GISH BIOMEDICAL, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 6/30/1995
- Days to Decision
- 305 days
- Submission Type
- Summary