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FDA 510(k), K213857, HeartFlow Analysis
FDA 510(k), K213857, HeartFlow Analysis
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510(K) Number: K213857
Device Name: HeartFlow Analysis
Manufacturer: HeartFlow, Inc.
Device Classification Name: Coronary Vascular Physiologic Simulation Software
Regulation Number: 870.1415
Classification Product Code: PJA
Date Received: 12/10/2021
Decision Date: 10/14/2022
Regulation Medical Specialty: Cardiovascular
Device Name: HeartFlow Analysis
Manufacturer: HeartFlow, Inc.
Device Classification Name: Coronary Vascular Physiologic Simulation Software
Regulation Number: 870.1415
Classification Product Code: PJA
Date Received: 12/10/2021
Decision Date: 10/14/2022
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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