FDA Device Establishments · JSON-LD · Markdown
FEI 3005994106 · Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device · Status: Active
| FEI Number | 3005994106 |
|---|---|
| Owner / Operator | Surmodics, Inc (#10023361) |
| Address | IDA Business Park, Ballinasloe, Co. Galway, H53 K8P4, IE |
| Mandatory US Agent | Surmodics |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 2 |
| Product codes (top 20) | LIT, DQY |
| Regulation § (21 CFR) | 870.1250 |
| Proprietary names | FirstChoice Ultra High Pressure PTA Balloon Catheters; Passeo-35 HP PTA Balloon Dilatation Catheter |
Source: openFDA. Public-domain (CC0).