FDA Device Establishments · JSON-LD · Markdown
FEI 3015551113 · Manufacture Medical Device · Status: Active
| FEI Number | 3015551113 |
|---|---|
| Owner / Operator | Nipro Vascular Innovations Americas, Inc. (#10025766) |
| Address | 28 Crosby Drive, Suite 100, Bedford, MA, US |
| Registration expiry | 2026 |
| Initial importer flag | Y |
| Registered products | 3 |
| Product codes (top 20) | OBJ, IYO, OGZ |
| Regulation § (21 CFR) | 870.1200, 892.1560 |
| Proprietary names | Clarispro HD-IVUS Imaging Catheter (TVC-E195-42); Dualpro IVUS+NIRS Imaging Catheter (TVC-C195-42); Makoto Intravascular Imaging System (TVC-MC10/TVC-MC10i) |
Source: openFDA. Public-domain (CC0).