LLD
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Port & Catheter, Implanted, Subcutaneous, Intraperitoneal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5965
- Medical specialty
- General Hospital
- Flags
- Implant
- Adverse events (MAUDE)
- 1992: 2 · 1993: 6 · 1995: 1
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 |
|---|---|---|
| PORT-A-CATH IMPLANTABLE DRUG DELIVERY SYSTEM (K880072) | Pharmacia Deltec, Inc. | 1988-03-29 |
| PORT-A-CATH IMPLANTABLE CATHETER SYSTEM (K864552) | Pharmacia, Inc. | 1987-03-31 |
| INTESTOPLANT (K862412) | Burron Medical Products, Inc. | 1986-11-13 |
| PORT-A-CATH IMPLANTABLE CATHETER SYS (K832906) | Pharmacia, Inc. | 1984-03-06 |
Track LLD automatically
Every clearance here is in the API, with alerts when new ones post.