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
- 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
- K022238MYOCARDIAL LEAD IMPLANT TOOL, MODEL 106261Cleared 510(K)
- K964445OCTOPUS TISSUE STABILIZER (28001/28002/28003/28004/28005/28006)1Cleared 510(K)
- K962771BURKE CONGENITAL THORACOSCOPY INSTRUMENTS1Cleared 510(K)
- K955689RNS STERILE, DISPOSABLE DIGITAL ANGIOGRAPHIC TRAY1Cleared 510(K)
- K960139G.E. STERILE ANGIOGRAPHIC TRAY1Cleared 510(K)
- K960144G.E. STERILE CT BIOPSY TRAY1Cleared 510(K)
- K960143G.E. STERILE DIGITAL ANGIOGRAPHIC TRAY1Cleared 510(K)
- K934727REPLACEMENT PARTS FOR CPI 6888 LEAD TUNNELER1Cleared 510(K)
- K900379HYCULT DIAMOND CORONARY BYPASS KNIFE1Cleared 510(K)
- K896307INSULATION PAD1Cleared 510(K)
- K894738MODEL 6888 LEAD TUNNELER1Cleared 510(K)
- K893436MODIFIED STERILIZATION METHOD OF PTI HEART-LIFT1Cleared 510(K)
- K892804NEWCHILL(TM) CARDIAC INSULATOR1Cleared 510(K)
- K891000MODIFIED EXTERNAL PAD1Cleared 510(K)
- K890432DEKNATEL HIGH PRECISION VASCULAR PUNCH(TM)1Cleared 510(K)
- K890707PHRENIC NERVE PAD & NERVE PAD W/1/4 PERCARDIAL1Cleared 510(K)
- K882981PTI INTRA-ART CORONARY ARTERY RETRACTION CLIP1Cleared 510(K)
- K883135PTI HEART-LIFT(TM) CARDIAC ELEVATOR (STERILE)1Cleared 510(K)
- K882367METATECH MICROCLIP APPLICATOR1Cleared 510(K)
- K881796UMI DISPOSABLE BUTTERFLY STYLE PUNCTURE NEEDLE1Cleared 510(K)
- K88247926MM DIAMETER HANCOCK* TROCAR BLADE AND TIP1Cleared 510(K)
- K881717PTI HEART-LIFT(TM) CARDIAC SUPPORT SLING (STERILE)1Cleared 510(K)
- K881392CARDICAD(TM)1Cleared 510(K)
- K875016BIOSURGE MODEL ILVC-11Cleared 510(K)
- K874960CARDIOVASCULAR SURGICAL INSTRUMENTS1Cleared 510(K)
- K864461MEDSURG CUSTOM CARDIOVASCULAR PROCEDURE TRAY1Cleared 510(K)
- K861745VICKERS ERGOMATIC MICROSURG INSTRU CARDIAC SET1Cleared 510(K)
- K851825SCANLAN TUNNELER, SHEATH & TIP1Cleared 510(K)
- K851834MANAN GWI GUIDE WIRE INTRODUCER1Cleared 510(K)
- K851832NAMAN POTTS COURNAND NEEDLE1Cleared 510(K)
- K851833MANAN SELDINGER NEEDLE1Cleared 510(K)
- K851152MC-4000 SURGICAL INSTRUMENTS CARDIOVASCULAR1Cleared 510(K)
- K851140TELEFLEX MEDICAL INTRODUCER NEEDLE1Cleared 510(K)
- K850394LEMAITRE RETROGRADE VALVULOTOME-MANU-SURGICA INSTR1Cleared 510(K)
- K844584GORE-TEX TUNNELER1Cleared 510(K)
- K841468PMA ANGIOGRAPHY TRAY1Cleared 510(K)
- K840305CATEGORY 1 CIRCULATORY SYSTEM DEVICE1Cleared 510(K)
- K833547ROTARY VASCULAR KNIFE1Cleared 510(K)
- K831455LEATHER VALVE CUTTER1Cleared 510(K)
- K830471KELLY-WICK TANNELER1Cleared 510(K)
- K823764SCANLAN SINGLE-USE AORTA PUNCH1Cleared 510(K)
- K823094CARDIAC ELEVATOR1Cleared 510(K)
- K822829ROTARY VASCULAR KNIFE1Cleared 510(K)
- K821569LEATHER VALVULOTOME1Cleared 510(K)
- K820258DEKNATEL DISPOSABLE GOOSEN VASCULAR PNCH1Cleared 510(K)
- K813284VENOUS CANNULA TRAY1Cleared 510(K)
- K810890NEOLOOPS1Cleared 510(K)
- K802079DEKNATEL GOOSEN VASCULAR PUNCH BLADES1Cleared 510(K)
- K801393AIR ASPIRATOR NEEDLE1Cleared 510(K)
- K800122HANCOCK AORTIC PUNCH1Cleared 510(K)
- K792576CASTROVIEJO VASCULAR SCISSORS1Cleared 510(K)
- K792088AORTIC OCCLUDER #0003901Cleared 510(K)
- K791710CARDIOVASCULAR INSTRUMENTS-VARIOUS1Cleared 510(K)
- K791370SILICONE SURGICAL VESSEL LOOPS1Cleared 510(K)
- K790124GRAFT TUNNELER1Cleared 510(K)
- K781336SURGITEK DISPOSABLE FLO-RESTER1Cleared 510(K)
- K780567AORTIC PUMP1Cleared 510(K)
- K780247IMPCO DISPOSABLE AORTIC PUNCH1Cleared 510(K)
- K771625LEININGEO AORTIC PUNCH #310-395 & 3971Cleared 510(K)
- K771026HUANG VEIN HOLDER, #21-80111Cleared 510(K)
- K761328ANASTOMASIS OCCLUDER1Cleared 510(K)
- K76116167-8006 DARLING-LINTON AORTIC TOURN.1Cleared 510(K)
- K760792SCISSOR - 1.5MM PROBE POINT, ANGLED1Cleared 510(K)
- K760791COOLEY ANGLED SCISSOR - 1MM PROBE POINT1Cleared 510(K)
- K760645CAROTID ARTERY ARTERIOTOMY CLOSURE CLAMP1Cleared 510(K)
- K760648TIBIAL ARTERY CLAMP W/ATRAUGRIP JAWS1Cleared 510(K)
- K760646CAROTID ARTERY CLAMP W/PILLING LMM1Cleared 510(K)
- K760624SMALL VESSEL CANNULA1Cleared 510(K)
- K760351CATHETER, ARGYLE THORACIC1Cleared 510(K)
- K760136CATHETER, THORACIC DRAIN1Cleared 510(K)
- K760087TAPE, VASCULAR, 1/4 DACRON1Cleared 510(K)
- 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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SURGITEK DISPOSABLE FLO-RESTER
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K781336
- 510(k) Type
- Traditional
- Applicant
- MEDICAL ENGINEERING CORP.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 10/10/1978
- Days to Decision
- 68 days