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
- K220635Heater-Cooler System 3T2Cleared 510(K)
- K212657Quantum Heater-Cooler2Cleared 510(K)
- K191402Heater-Cooler System 3T2Cleared 510(K)
- K140012SORIN FLEXTHERM2Cleared 510(K)
- K130300HEATER-COOLER UNIT HCU 402Cleared 510(K)
- K122813HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEM2Cleared 510(K)
- K102147CARDIOQUIP MODULAR COOLER-HEATER MODEL MCH-10002Cleared 510(K)
- K071521TERUMO HX2 TEMPERATURE MANAGEMENT SYSTEM2Cleared 510(K)
- K052601STOCKERT HEATER-COOLER SYSTEM 3T2Cleared 510(K)
- K031544HEATER COOLER UNIT, MODEL HCU 302Cleared 510(K)
- K014016ENGUARD CHC DUAL RESERVOIR CARDIOPLEGIA HEATER/COOLER2Cleared 510(K)
- K003145ORIGEN BLADDER HOLDER2Cleared 510(K)
- K001520ALPHA OMEGA DUAL COOLER-HEATER2Cleared 510(K)
- K945720JOSTRA HL-15 MODULAR HEART-LUNG MACHINE (HEREINAFTER CALLED THE HL-15 OR THE DEVICE2Cleared 510(K)
- K896973CARDIAC COOLING JACKET, 30% ENLARGED, MODEL CJ-3202Cleared 510(K)
- K896971CARDIAC COOLING JACKET, 8 CM, MODEL CJ-4202Cleared 510(K)
- K896972CARDIAC COOLING JACKET, 12 CM, MODEL CJ-5202Cleared 510(K)
- K896974CARDIAC COOLING JACKET, 8 CM, MODEL CJ-1202Cleared 510(K)
- K896975CARDIAC COOLING JACKET, 30% REDUCED, MODEL CJ-2202Cleared 510(K)
- K896393CARDIAC COOLING JACKED, 16 CM, MODEL CJ-6202Cleared 510(K)
- K893940POLYSTAN HEATER-COOLER UNIT2Cleared 510(K)
- K883603SARNS TEMP. CONTROL AND MONITOR SYSTEM (TCM II)2Cleared 510(K)
- K873924PTI HEART-CHILL POUCH/PAD SLING (STERILE)2Cleared 510(K)
- K874927PTI HEART-CHILL(TM) CARDIAC INSULATING JACKET2Cleared 510(K)
- K873699ECMO-TEMP (TM) BLOOD WARMING DEVICE2Cleared 510(K)
- K873813SARNS WARMER, PART #164975 AND #1649802Cleared 510(K)
- K841402TEMPERATURE CONTROL & MONITOR2Cleared 510(K)
- K831677HYPER-HYPOTHERMIA UNIT HYPO 10-2002Cleared 510(K)
- K822874THERMOSTATIC WATER MIXING VALVE TWV102Cleared 510(K)
- K810647SHILEY OXYGENATOR THERMISTOR PROBE2Cleared 510(K)
- 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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ORIGEN BLADDER HOLDER
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K003145
- 510(k) Type
- Traditional
- Applicant
- ORIGEN BIOMEDICAL, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 4/20/2001
- Days to Decision
- 192 days
- Submission Type
- Summary