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
- K202108External Counterpulsation System, Soulaire2Cleared 510(K)
- K191955Enhanced External Counter Pulsation Device Plus Omay-A2Cleared 510(K)
- K190683External Counterpulsation System2Cleared 510(K)
- K173483Pure Flow External Counter-Pulsation Device2Cleared 510(K)
- K152115Renew NCP-5 External Counterpulsation System2Cleared 510(K)
- K130439EXTERNAL COUNTERPULSATION DEVICE WITH SP02 MORNITORING2Cleared 510(K)
- K082134CIRCULATOR BOOT2Cleared 510(K)
- K081359GENESIS ECP2Cleared 510(K)
- K052611ECP HEALTH SYSTEM, MODEL 20052Cleared 510(K)
- K050172CARDIASSIST COUNTER PULSATION SYSTEM SERIES 4000/50002Cleared 510(K)
- K042413ACS MODEL NCP-22Cleared 510(K)
- K033617EECP THERAPY SYSTEM MODEL TS4 WITH/WITHOUT PLUSE OXIMETRY2Cleared 510(K)
- K033657MOBILE EXTERNAL COUNTER PULSATION SYSTEM ANGIONEW-V2Cleared 510(K)
- K030587EXTERNAL COUNTERPULSATION (ECP) MODEL US-ECP2Cleared 510(K)
- K030532CPCA2000 COUNTERPULSATION SYSTEM2Cleared 510(K)
- K023701ANGIONEW-IV2Cleared 510(K)
- K021340AECP-A, AUTOMATIC EXTERNAL COUNTERPULSATION DEVICE2Cleared 510(K)
- K022078SOLA, COUNTER-PULSATION, MODEL SECP-S2Cleared 510(K)
- K023427CARDIASSIST COUNTERPULSATION SYSTEM, MODEL MARK 30002Cleared 510(K)
- K023016NICORE MODEL NCP-1 EXTERNAL COUNTERPULSATION DEVICE2Cleared 510(K)
- K022107CARDIASSIST COUNTERPULSATION SYSTEM, MODEL MARK 30002Cleared 510(K)
- K020857EECP THERAPY SYSTEM MODEL TS3 WITH PULSE OXIMETRY AND ENHANCED EXTERNAL COUNTERPULSATION EECP MC-2 EXTERNAL COUNTER2Cleared 510(K)
- K012141AECP-A, AUTOMATIC EXTERNAL COUNTERPULSATION DEVICE2Cleared 510(K)
- K010261CARDIOMEDICS ECP SYSTEM2Cleared 510(K)
- K003469EECP THERAPY SYSTEM, MODEL TS32Cleared 510(K)
- K980937NICORE MODEL ESP -12Cleared 510(K)
- K971026THE CIRCULATOR BOOT2Cleared 510(K)
- K940264VASOGENICS EECP-MC22Cleared 510(K)
- K882401STONY BROOK MODEL EECP-MC12Cleared 510(K)
- K872034CARDIOMEDICS EXTERNAL COUNTERPULSATION SYSTEM2Cleared 510(K)
- K833627CIRCULATOR MINIBOOT2Cleared 510(K)
- K792430CARDIASSIST EXTERNAL COUNTERPULSATION2Cleared 510(K)
- K792354THE CIRCULATOR BOOT2Cleared 510(K)
- DROPacemaker, Cardiac, External Transcutaneous (Non-Invasive)2Product Code
- DRPTourniquet, Automatic Rotating2Product Code
- DWJSystem, Thermal Regulating2Product Code
- DXECatheter, Embolectomy2Product Code
- DXFCatheter, Septostomy2Product Code
- 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
- 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
ACS MODEL NCP-2
- Page Type
- Cleared 510(K)
- 510(k) Number
- K042413
- 510(k) Type
- Traditional
- Applicant
- Applied Cardiac Systems
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 12/9/2004
- Days to Decision
- 93 days
- Submission Type
- Summary