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FDA 510(k), K182149, FFRangio System
FDA 510(k), K182149, FFRangio System
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510(K) Number: K182149
Device Name: FFRangio System
Manufacturer: CathWorks Ltd
Device Classification Name: Angiographic Coronary Vascular Physiologic Simulation Software
Regulation Number: 870.1415
Classification Product Code: QEK
Date Received: 08/08/2018
Decision Date: 12/19/2018
Regulation Medical Specialty: Cardiovascular
Device Name: FFRangio System
Manufacturer: CathWorks Ltd
Device Classification Name: Angiographic Coronary Vascular Physiologic Simulation Software
Regulation Number: 870.1415
Classification Product Code: QEK
Date Received: 08/08/2018
Decision Date: 12/19/2018
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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