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
- K101186AFFINITY VARD SUB-ASSEMBLY FOR CPS (CARMEDA COATED), PURGELINE (UNCOATED), HOLDING BAG2Cleared 510(K)
- K082412VENOUS BUBBLE TRAP, MODEL VBT 160; VENOUS BUBBLE TRAP WITH BIOLINE COATING, MODEL BE-VBT 160, BEQ-VBT 1602Cleared 510(K)
- K004046COBE VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR, COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR2Cleared 510(K)
- K002591COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR2Cleared 510(K)
- K990514MODIFICATION OF BARD QUANTUM CVR, MODEL H-6770VR2Cleared 510(K)
- K984322DIDECO D920, LILLIPUT 1 TWIN RESERVOIR2Cleared 510(K)
- K962726BARD QUANTUM CVR2Cleared 510(K)
- K941654SARNS FILTERED VENOUS RESERVIOR MODIFICATION2Cleared 510(K)
- K933496MAXIMA FILTERED HARDSHELL RESERVIOR2Cleared 510(K)
- K912915SARNS NON-FILTERED VENOUS RESERVOIR2Cleared 510(K)
- K911789MINIMAX (TM) HARDSHELL VENOUS RES W/INTE CARD FILT2Cleared 510(K)
- K910568MODEL 5866-46 SLEEVE KIT2Cleared 510(K)
- K902437COBE CARDIOTOMY RESERVOIR WITH OR WITHOUT FILTER2Cleared 510(K)
- K902856BARD FILTERED CARDIOTOMY RESERVOIR2Cleared 510(K)
- K902355MCR4000 & MCR4000F CARDIOTOMY RESERVOIR2Cleared 510(K)
- K874924CAP-35 AND CAP35 F2Cleared 510(K)
- K872167CARDIOTOMY/MEDIASTINAL AUTO. RESERVOIR CATR-35002Cleared 510(K)
- K870792THORASTAT ATR-XXXX2Cleared 510(K)
- K860775MEDIASTINAL AUTOTRANSFUSION SYSTEM2Cleared 510(K)
- K860702SARNS FILTERED CARDIOTOMY RESERVOIR2Cleared 510(K)
- K855049MODIFIED MODEL SC4000(F) CARDIOTOMY RESERVOIR2Cleared 510(K)
- K853503SHILEY 3L CARDIOTOMY RESERVOIR2Cleared 510(K)
- K851004CARDIOTOMY RESERVOIR BRS-XXX & HOLDER BRS-HXX2Cleared 510(K)
- K844803POLYESTER CARDIOTOMY RESERVOIR, FILTERED & UNFILTE2Cleared 510(K)
- K842373VENOUS RESERVOIR-BMR-1500-HARD SHELL2Cleared 510(K)
- K840610SCIMED MODEL SC40002Cleared 510(K)
- K834041CARDIOTOMY RESERVOIR SC3500F2Cleared 510(K)
- K832811SHILEY 3L CARDF PLUS2Cleared 510(K)
- K830727CARDIOTOMY RESERVOIR-FILTERED & NON2Cleared 510(K)
- K823731CARDF2Cleared 510(K)
- K821538CAPIOX CR-CARDIOTOMY RESERVOIR2Cleared 510(K)
- K820954SCIMED MODEL SC 30002Cleared 510(K)
- K801375SHILEY CARDIOTOMY RESERVOIR W/FILTER2Cleared 510(K)
- K801360CARDIOTOMY RESERVOIR WITH FILTER2Cleared 510(K)
- DTQConsole, Heart-Lung Machine, Cardiopulmonary Bypass2Product Code
- DTRHeat-Exchanger, Cardiopulmonary Bypass2Product Code
- 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
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
CAP-35 AND CAP35 F
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K874924
- 510(k) Type
- Traditional
- Applicant
- GISH BIOMEDICAL, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 1/19/1988
- Days to Decision
- 48 days