DWQ · Stripper, Vein, External
Cardiovascular · 21 CFR 870.4885 · Class 2
Overview
| Product Code | DWQ |
|---|---|
| Device Name | Stripper, Vein, External |
| Regulation | 21 CFR 870.4885 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 3rd-Party Reviewable | Yes |
Identification
An external vein stripper is an extravascular device used to remove a section of a vein.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (8 of 8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K212894 | PhasTIPP | LeMaitre Vascular, Inc. | Mar 31, 2022 | SESE |
| K041453 | SMITH & NEPHEW TUMESCENT CATHETER INVERSION SYSTEM, MODEL 7210023 | Smith & Nephew, Inc. | Jul 22, 2004 | SESE |
| K032387 | TRIVEX SYSTEM | Smith & Nephew, Inc. | Oct 29, 2003 | SESE |
| K905528 | URESIL VALVE CUTTER | Uresil Corp. | Apr 18, 1991 | SESE |
| K904507 | PILLING BRUSH VALVULOTOME | Pilling Co. | Mar 1, 1991 | SESE |
| K885046 | INSITUCAT VALVE STRIPPER | Aesculap Instruments Corp. | Feb 28, 1990 | SESE |
| K872157 | HALL VEIN STRIPPER | Solco Basle, Inc. | Jul 7, 1987 | SESE |
| K811910 | VEIN-TRAP TM | Atrium Medical Corp. | Jul 20, 1981 | SESE |
Top Applicants
- Smith & Nephew, Inc. — 2 clearances
- Uresil Corp. — 1 clearance
- Solco Basle, Inc. — 1 clearance
- Pilling Co. — 1 clearance
- LeMaitre Vascular, Inc. — 1 clearance
