FDA Device Establishments · JSON-LD · Markdown
FEI 3010605876 · Complaint File Establishment per 21 CFR 820.198 Remanufacture Medical Device Manufacture Medical Device · Status: Active
| FEI Number | 3010605876 |
|---|---|
| Owner / Operator | Coapt, LLC (#10045459) |
| Address | 303 W. Institute Pl., Suite 200, Chicago, IL, US |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 2 |
| Product codes (top 20) | IQZ, GXY |
| Regulation § (21 CFR) | 890.3420, 882.1320 |
| Proprietary names | COMPLETE CONTROL System Gen2 |
Source: openFDA. Public-domain (CC0).