Stripper, Vein, External
FDA product code DWQ · Class II (moderate risk) · 21 CFR 870.4885 · Cardiovascular
8510(k) clearances
0PMA approvals
2recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K212894 | PhasTIPPDWQ · Traditional | LeMaitre Vascular, Inc. | 03/31/2022SE |
| K041453 | Smith & Nephew Tumescent Catheter Inversion System, Model 7210023DWQ · Traditional | Smith & Nephew, Inc. | 07/22/2004SE |
| K032387 | Trivex SystemDWQ · Traditional | Smith & Nephew, Inc. | 10/29/2003SE |
| K905528 | Uresil Valve CutterDWQ · Traditional | Uresil Corp. | 04/18/1991SE |
| K904507 | Pilling Brush ValvulotomeDWQ · Traditional | Pilling Co. | 03/01/1991SE |
| K885046 | Insitucat Valve StripperDWQ · Traditional | Aesculap Instruments Corp. | 02/28/1990SE |
| K872157 | Hall Vein StripperDWQ · Traditional | Solco Basle, Inc. | 07/07/1987SE |
| K811910 | Vein-Trap TMDWQ · Traditional | Atrium Medical Corp. | 07/20/1981SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1294-2015 Class III | LeMaitre Vascular Tumescent Catheter Inversion (TCI) System. The TCI System is intended…Mislabeled with an incorrect expiration date | LeMaitre Vascular, Inc. | 02/24/2015Terminated |
| Z-1105-2007 | Smith & Nephew TRIVEX System Pneumatic Footswitch, Part #7209791; distributed by Smith &…Build-up of static charge in Pneumatic Footswitch tubing may cause control unit to reset to default settings… | Smith & Nephew, Inc Endoscopy Division | 10/12/2004Terminated |