FDA Device Establishments · JSON-LD · Markdown
FEI 3005462046 · Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device · Status: Active
| FEI Number | 3005462046 |
|---|---|
| Owner / Operator | Philips Medical Systems International BV (#2939520) |
| Address | 5055 BRANDIN COURT, FREMONT, CA, US |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | PNO |
| Regulation § (21 CFR) | 870.1250 |
| Proprietary names | Angiosculpt OTW PTA Scoring Balloon Catheter |
Source: openFDA. Public-domain (CC0).