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
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Cardiovascular Therapeutic DevicesCFR Sub-Part
- DRKDc-Defibrillator, High Energy, (Including Paddles)3Product Code
- DRLTester, Defibrillator2Product Code
- DRMCompressor, Cardiac, External2Product Code
- DRNDevice, Counter-Pulsating, External2Product Code
- DROPacemaker, Cardiac, External Transcutaneous (Non-Invasive)2Product Code
- DRPTourniquet, Automatic Rotating2Product Code
- DWJSystem, Thermal Regulating2Product Code
- DXECatheter, Embolectomy2Product Code
- DXFCatheter, Septostomy2Product Code
- K252419HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX)2Cleared 510(K)
- K251007CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F)2Cleared 510(K)
- K243193Cross Wise™ Multi-Use RF Adapter Cable2Cleared 510(K)
- K242076VersaCross™ RF Wire2Cleared 510(K)
- K241414CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C); CrossWise RF Adapter Cable (Model CW-1002)2Cleared 510(K)
- K240900HOTWIRE™ RF Guidewire2Cleared 510(K)
- K232852Cross Vascular RF Transseptal Needle, Cross Vascular Connection Cable2Cleared 510(K)
- K221528Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy Catheter2Cleared 510(K)
- K211910Z-6 Atrioseptostomy Catheter2Cleared 510(K)
- K182399Park Blade Septostomy Catheter2Cleared 510(K)
- K150709ProTrack RF Anchor Wire2Cleared 510(K)
- K073326NRG TRANSSEPTAL NEEDLE2Cleared 510(K)
- K031949TORONTO RF SEPTOSTOMY CATHETER, MODEL TSC-50-752Cleared 510(K)
- K011557PTA, PTV, ATRIOSEPTOSTOMY, ANGIOGRAPHIC, SIZING CATHETERS2Cleared 510(K)
- K990284BAYLIS MEDICAL RF SEPTOSTOMY GENERATOR, NYKANEN RF SEPTOSTOMY CATHETER, BAYLIS MEDICAL CONNECTOR CABLE2Cleared 510(K)
- K001804NUMED Z-5 ATRIOSEPTOSTOMY CATHETER2Cleared 510(K)
- K860806REGULATED PRESSURE INJECTOR2Cleared 510(K)
- K801031BLADE SEPTOSTOMY CATHETER2Cleared 510(K)
- JOWSleeve, Limb, Compressible2Product Code
- LDDDc-Defibrillator, Low-Energy, (Including Paddles)2Product Code
- LHXTrousers, Anti-Shock2Product Code
- LIXAid, Cardiopulmonary Resuscitation2Product Code
- LOXCatheters, Transluminal Coronary Angioplasty, Percutaneous2Product Code
- MKJAutomated External Defibrillators (Non-Wearable)3Product Code
- MMXDevice, Percutaneous Retrieval2Product Code
- MPCAtrial Defibrillator3Product Code
- MPDAuxiliary Power Supply (Ac Or Dc) For Low-Energy Dc-Defibrillator2Product Code
- MPEAuxiliary Power Supply (Acor Dc) For External Transcutaneous Cardiac Pacemaker2Product Code
- NSAOver-The-Counter Automated External Defibrillator3Product Code
- NZEHyperthermia Monitor2Product Code
- PJBCatheter Remote Control System2Product Code
- PLAEsophageal Thermal Regulation And Gastric Suctioning Device2Product Code
- PMJCpr Aid Feedback Device (No Software)2Product Code
- PMKCpr Aid Device Without Feedback1Product Code
- PPSSleeve, Head And Neck, Compressible2Product Code
- QEWPeripheral Mechanical Thrombectomy With Aspiration2Product Code
- QEXCoronary Mechanical Thrombectomy With Aspiration2Product Code
- QEYMechanical Thrombolysis Catheter2Product Code
- QEZAspiration Thrombectomy Catheter2Product Code
- QLZSeptostomy Catheter, Reprocessed2Product Code
- QMSAdjunctive Open Loop Fluid Therapy Recommender2Product Code
- Subpart F—Therapeutic DevicesCFR Sub-Part
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BLADE SEPTOSTOMY CATHETER
- Page Type
- Cleared 510(K)
- 510(k) Number
- K801031
- 510(k) Type
- Traditional
- Applicant
- COOK, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 7/28/1980
- Days to Decision
- 88 days