MAJ
6 FDA 510(k) clearances · Product code
193 daysmedian time to decision
583 days90th percentile
6clearances measured
FDA profile
- Official device name
- Catheter, Percutaneous, Intraspinal, Short Term
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5120
- Medical specialty
- Anesthesiology
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 1995: 1 · 2000: 2 · 2025: 18 · 2026: 15
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 |
|---|---|---|
| MEDTRONIC ALGOLINE INTRASPINAL CATHETER SYSTEM (K965251) | Medtronic Vascular | 1997-03-18 |
| MEDTRONIC MODEL 3864C & 3865C TEMPORARY SCREENING LEAD/CATHETER KIT (K945413) | Medtronic Vascular | 1995-05-24 |
| TEMPORARY SCREENING LEAD/ CATHETER KIT (K934939) | Medtronic Vascular | 1995-05-24 |
| SUBCUTANEOUS TUNNELING NEEDLE AND HANDLES (K930218) | Concord/Portex | 1993-07-27 |
| IPI ALGO-LINE CATHETER (K911382) | Pudenz-Schulte Medical Research Corp. | 1991-07-18 |
| LIFECARE CONT. EPIDURAL CATH. FOR MORPHINE SULFATE (K893766) | Abbott Laboratories | 1989-11-01 |
Track MAJ automatically
Every clearance here is in the API, with alerts when new ones post.