FDA Device Establishments · JSON-LD · Markdown
FEI 3016257349 · Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198 · Status: Active
| FEI Number | 3016257349 |
|---|---|
| Owner / Operator | Philips Medical Systems International BV (#2939520) |
| Address | 5905 Nathan Lane North, Plymouth, MN, US |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | MCW |
| Regulation § (21 CFR) | 870.4875 |
| Proprietary names | Phoenix Pre-Deflected Atherectomy System 2.2mm x 130cm; Phoenix Pre-Deflected Atherectomy Catheter 2.2mm x 130cm; Phoenix Handle with Wire Support Clip |
Source: openFDA. Public-domain (CC0).