Chrysalis Intelligence · Sponsors · HeartFlow, Inc.

HeartFlow, Inc.

Redwood City, CA, US · 3 510(k) clearances

Total clearances
3
2021-01-08 → 2025-07-18
Last 12 months
0
Product codes
1
Most recent
2025-07-18
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
PJA Coronary Vascular Physiologic Simulation Software Class II Cardiovascular 3 2025-07-18
Filings

All 510(k) clearances (3)

Date K-number Device Code Class Specialty
2025-07-18 K250902 HeartFlow Analysis PJA Class II Cardiovascular
2022-10-14 K213857 HeartFlow Analysis PJA Class II Cardiovascular
2021-01-08 K203329 HeartFlow Analysis PJA Class II Cardiovascular