FFRct— 510(k) K182035
Substantially EquivalentHeartFlow, Inc.
FDA 510(k) clearance K182035 for FFRct, Substantially Equivalent on 2018-12-06. Applicant: HeartFlow, Inc.. Device class: 2.
Clearance details
- Applicant
- HeartFlow, Inc.
- Product code
- Code PJA
- Device class
- Class 2
- Regulation
- 21 CFR 870.1415
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Redwood City, CA, US
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