HeartFlow FFRct Analysis
FDA 510(k) clearance K190925 · decided 2019-08-15
Clearance details
- K-number
- K190925
- Device name
- HeartFlow FFRct Analysis
- Applicant
- HeartFlow, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2019-04-09
- Decision date
- 2019-08-15
- Days to decision
- 128 days
- Clearance type
- Traditional
- Product code
- PJA
- Device class
- 2
- Regulation number
- 870.1415
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Redwood City, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| HeartFlow Analysis (K250902) | HeartFlow, Inc. | 2025-07-18 |
| HeartFlow Analysis (K213857) | HeartFlow, Inc. | 2022-10-14 |
| DEEPVESSEL FFR (K213657) | Keyamed Na, Inc. | 2022-04-01 |
| HeartFlow Analysis (K203329) | HeartFlow, Inc. | 2021-01-08 |
| FFRct (K182035) | HeartFlow, Inc. | 2018-12-06 |
| FFRct (K161772) | HeartFlow, Inc. | 2016-08-24 |
| FFRct (K152733) | HeartFlow, Inc. | 2016-01-13 |
| HEARTFLOW FFRCT (DEN130045) | Heartflow | 2014-11-26 |
Recalls involving this device
No recalls on record reference this clearance.