FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FFRct
K Number: K152733
·
Decision Jan 13, 2016
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
8
Applicant Total
7
Review Days
113
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- FFRct
- K Number
- K152733
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1415
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- HeartFlow, Inc.
- Date Received
- September 22, 2015
- Decision Date
- January 13, 2016
- Product Code
- PJA
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| PJA | Coronary Vascular Physiologic Simulation Software | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (PJA), ordered by most recent decision date.
HeartFlow Analysis
FDA 510(k)
FDA Class 2
·Cardiovascular
HeartFlow Analysis
FDA 510(k)
FDA Class 2
·Cardiovascular
DEEPVESSEL FFR
FDA 510(k)
FDA Class 2
·Cardiovascular
HeartFlow Analysis
FDA 510(k)
FDA Class 2
·Cardiovascular
HeartFlow FFRct Analysis
FDA 510(k)
FDA Class 2
·Cardiovascular
FFRct
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by HeartFlow, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K250902 | HeartFlow Analysis | Jul 18, 2025 | Substantially Equivalent |
| K213857 | HeartFlow Analysis | Oct 14, 2022 | Substantially Equivalent |
| K203329 | HeartFlow Analysis | Jan 8, 2021 | Substantially Equivalent |
| K190925 | HeartFlow FFRct Analysis | Aug 15, 2019 | Substantially Equivalent |
| K182035 | FFRct | Dec 6, 2018 | Substantially Equivalent |
| K161772 | FFRct | Aug 24, 2016 | Substantially Equivalent |