DWQ
8 FDA 510(k) clearances · Product code
129 daysmedian time to decision
450 days90th percentile
8clearances measured
FDA profile
- Official device name
- Stripper, Vein, External
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4885
- Medical specialty
- Cardiovascular
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 2004: 2 · 2005: 5 · 2006: 2 · 2008: 3 · 2018: 36 · 2019: 29
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 |
|---|---|---|
| PhasTIPP (K212894) | LeMaitre Vascular, Inc. | 2022-03-31 |
| SMITH & NEPHEW TUMESCENT CATHETER INVERSION SYSTEM, MODEL 7210023 (K041453) | Smith & Nephew, Inc. | 2004-07-22 |
| TRIVEX SYSTEM (K032387) | Smith & Nephew, Inc. | 2003-10-29 |
| URESIL VALVE CUTTER (K905528) | Uresil Corp. | 1991-04-18 |
| PILLING BRUSH VALVULOTOME (K904507) | Pilling Co. | 1991-03-01 |
| INSITUCAT VALVE STRIPPER (K885046) | Aesculap Instruments Corp. | 1990-02-28 |
| HALL VEIN STRIPPER (K872157) | Solco Basle, Inc. | 1987-07-07 |
| VEIN-TRAP TM (K811910) | Atrium Medical Corp. | 1981-07-20 |
Track DWQ automatically
Every clearance here is in the API, with alerts when new ones post.