GBP
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Catheter, Multiple Lumen
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4200
- Medical specialty
- General, Plastic Surgery
- Adverse events (MAUDE)
- 1992: 20 · 1993: 13 · 1994: 12 · 2000: 1 · 2001: 5
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| MENSINK-GOOSEN CATHETER (K844889) | Goosen Enterprises, Inc. | 1985-03-18 |
| MULTILUMEN INTRAVENOUS INFUSION CATHETER (K821220) | Clincal Instruments Corp. | 1982-07-09 |
| CATHETER, MULTIPLE LUMEN (K820446) | Dlp, Inc. | 1982-03-11 |
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Every clearance here is in the API, with alerts when new ones post.