FDA Device Establishments · JSON-LD · Markdown
FEI 3010410494 · Manufacture Device in the United States for Export Only · Status: Active
| FEI Number | 3010410494 |
|---|---|
| Owner / Operator | HighLife Medical (#10050888) |
| Address | 12 Goodyear Ste 125, Irvine, CA, US |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | DYE |
| Regulation § (21 CFR) | 870.3925 |
| Proprietary names | Sub-Annular Implant; Loop Placement Catheter; Trans-Septal Delivery Catheter; Valve Loading Tool; SAI Delivery Catheter; 28mm Mitral Heart Valve; 28mm Mitral Heart Valve, LAV |
Source: openFDA. Public-domain (CC0).