FDA Device Establishments · JSON-LD · Markdown
FEI 3015309643 · Export Device to the United States But Perform No Other Operation on Device · Status: Active
| FEI Number | 3015309643 |
|---|---|
| Owner / Operator | Merit Medical Systems, Inc. (#1721504) |
| Address | Unit 27, Suttons Business Park Sutton Park Avenue, Earley Reading, RG6 1AW, GB |
| Mandatory US Agent | MERIT MEDICAL SYSTEMS, INC. |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | KNQ |
| Regulation § (21 CFR) | 876.5365 |
| Proprietary names | Elation Fixed Wire Balloon; Elation5 Fixed Wire Balloon; Elation5 Wireguided Balloon |
Source: openFDA. Public-domain (CC0).