Stripper, Vein, External
The External Vein Stripper is a cardiovascular surgical instrument used to remove varicose or saphenous veins from the leg by passing the device through the vessel lumen and extracting it along with the vein, typically in the treatment of varicose vein disease. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DWQ and it is regulated under 21 CFR 870.4885 within the Cardiovascular medical specialty. This device is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- DWQ
- Device Class
- FDA class 2
- Regulation Number
- 870.4885
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K212894 | PhasTIPP | Mar 31, 2022 | Substantially Equivalent | LeMaitre Vascular, Inc. |
| K041453 | SMITH & NEPHEW TUMESCENT CATHETER INVERSION SYSTEM, MODEL 7210023 | Jul 22, 2004 | Substantially Equivalent | Smith & Nephew, Inc. |
| K032387 | TRIVEX SYSTEM | Oct 29, 2003 | Substantially Equivalent | Smith & Nephew, Inc. |
| K905528 | URESIL VALVE CUTTER | Apr 18, 1991 | Substantially Equivalent | Uresil Corp. |
| K904507 | PILLING BRUSH VALVULOTOME | Mar 01, 1991 | Substantially Equivalent | Pilling Co. |
| K885046 | INSITUCAT VALVE STRIPPER | Feb 28, 1990 | Substantially Equivalent | Aesculap Instruments Corp. |
| K872157 | HALL VEIN STRIPPER | Jul 07, 1987 | Substantially Equivalent | Solco Basle, Inc. |
| K811910 | VEIN-TRAP TM | Jul 20, 1981 | Substantially Equivalent | Atrium Medical Corp. |
FEI Numbers
This FDA classification entry is associated with 7 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.