HeartFlow FFRct Analysis— 510(k) K190925

Substantially Equivalent

HeartFlow, Inc.

FDA 510(k) clearance K190925 for HeartFlow FFRct Analysis, Substantially Equivalent on 2019-08-15. Applicant: HeartFlow, Inc..

Clearance details

Applicant: HeartFlow, Inc.
Product code: Code PJA
Advisory panel: Cardiovascular
Date received: 2019-04-09
Decision date: 2019-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redwood City, CA, US

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