LKG
8 FDA 510(k) clearances · Product code
103 daysmedian time to decision
205 days90th percentile
8clearances measured
FDA profile
- Official device name
- Port & Catheter, Implanted, Subcutaneous, Intraventricular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.5550
- Medical specialty
- Neurology
- Flags
- Implant
- Adverse events (MAUDE)
- 1992: 25 · 1993: 5 · 1994: 7 · 1995: 3
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 |
|---|---|---|
| CORDIS CSF RESERVOIR (K950315) | Cordis Corp. | 1995-05-09 |
| PORT-A-CATH PORTAL INTRODUCER FORCEPS (K881690) | Pharmacia Deltec, Inc. | 1988-05-20 |
| PORT-A-CATH IMPLANTABLE ACCESS SYSTEM - KIT CONF. (K881493) | Pharmacia Deltec, Inc. | 1988-05-20 |
| P-S MEDICAL VENTRICULAR ACCESS PORT (K874468) | Pudenz-Schulte Medical Research Corp. | 1988-02-11 |
| CSF-VENTRICULOSTOMY RESERVOIR (K874498) | Pudenz-Schulte Medical Research Corp. | 1988-02-11 |
| P-S MEDICAL CSF ACCESS DEV 15MM/25MM (K833822) | Pudenz-Schulte Medical Research Corp. | 1984-05-25 |
| HH SUBCUTANEOUS ACCESS PORT (K833672) | Holter-Hausner Intl. | 1984-03-06 |
| VENTRICULAR ACCESS SYSTEM (K823790) | American Heyer Schulte | 1983-04-28 |
Track LKG automatically
Every clearance here is in the API, with alerts when new ones post.