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FDA 510(k), K152733, FFRct
FDA 510(k), K152733, FFRct
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510(K) Number: K152733
Device Name: FFRct
Manufacturer: WINDI HARY
Device Classification Name: Coronary Vascular Physiologic Simulation Software
Regulation Number: PJA
Classification Product Code: 09/22/2015
Date Received: 01/13/2016
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: FFRct
Manufacturer: WINDI HARY
Device Classification Name: Coronary Vascular Physiologic Simulation Software
Regulation Number: PJA
Classification Product Code: 09/22/2015
Date Received: 01/13/2016
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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