FFRct— 510(k) K182035
Substantially EquivalentHeartFlow, Inc.
FDA 510(k) clearance K182035 for FFRct, Substantially Equivalent on 2018-12-06. Applicant: HeartFlow, Inc..
Clearance details
- Applicant
- HeartFlow, Inc.
- Product code
- Code PJA
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Redwood City, CA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.