FEW
6 FDA 510(k) clearances · Product code
132 daysmedian time to decision
309 days90th percentile
6clearances measured
FDA profile
- Official device name
- Catheter, Malecot
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5090
- Medical specialty
- Gastroenterology, Urology
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 1997: 2 · 1998: 3 · 2000: 2 · 2002: 1 · 2004: 2 · 2005: 2
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 |
|---|---|---|
| UNIVERSA PERCULTANEOUS DRAINAGE CATHETER (K140085) | Cook Incorporated | 2014-11-18 |
| BARD MALECOT AND PEZZER DRAINS (K070879) | C.R. Bard, Inc. | 2007-04-24 |
| MANAN MALECOT BASKET DRAINAGE CATHETER (K981258) | Medical Device Technologies, Inc. | 1998-04-22 |
| MANAN MALECOT BASKET DRAINAGE CATHETER (K954147) | Manan Medical Products, Inc. | 1996-03-26 |
| SILICONE MALECOT CATHETER WITH PEZZER/MUSHROOM TIP (K954116) | Technical Products, Inc. | 1995-11-06 |
| OLYMPIC SMART SCALE CARE CENTER (K920423) | Olympic Medical Corp. | 1992-06-11 |
Track FEW automatically
Every clearance here is in the API, with alerts when new ones post.