FDA Device Establishments · JSON-LD · Markdown
FEI 3021637148 · Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198 · Status: Active
| FEI Number | 3021637148 |
|---|---|
| Owner / Operator | HeartFlow, Inc. (#10048116) |
| Address | 135 Main St Ste 1000, San Francisco, CA, US |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 2 |
| Product codes (top 20) | PJA, LLZ |
| Regulation § (21 CFR) | 870.1415, 892.2050 |
| Proprietary names | HeartFlow FFRCT Analysis |
Source: openFDA. Public-domain (CC0).