510(k) K182035
- Device
- FFRct
- Applicant
- HeartFlow, Inc
- 510(k) number
- K182035
- Product code
- PJA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-12-06
- Date received
- 2018-07-30
- Regulation
- 870.1415
- Classification name
- Coronary Vascular Physiologic Simulation Software
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Windi Hary
- Address
- 1400 Seaport Blvd., Bldg. B Redwood City CA US 94063 94063
FDA Registration Numbers#
- 3025430791
- 3021637148
Source Documents#
Other 510(k) Records For Product Code PJA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250902 | HeartFlow Analysis | HeartFlow, Inc. | 2025-07-18 |
| K213857 | HeartFlow Analysis | HeartFlow, Inc. | 2022-10-14 |
| K213657 | DEEPVESSEL FFR | Keyamed Na, Inc. | 2022-04-01 |
| K203329 | HeartFlow Analysis | HeartFlow, Inc. | 2021-01-08 |
| K190925 | HeartFlow FFRct Analysis | HeartFlow, Inc. | 2019-08-15 |
| K161772 | FFRct | HeartFlow, Inc. | 2016-08-24 |
| K152733 | FFRct | HeartFlow, Inc. | 2016-01-13 |
| DEN130045 | HEARTFLOW FFRCT | Heartflow | 2014-11-26 |
Legacy Summary#
summary
FDA Review#
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