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)
Show All 33 Submissions
- 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
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External Counterpulsation System, Soulaire
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K202108
- 510(k) Type
- Special
- Applicant
- Vamed Medical Instrument Co., Ltd.
- Country
- China
- FDA Decision
- Substantially Equivalent
- Decision Date
- 8/28/2020
- Days to Decision
- 29 days
- Submission Type
- Summary