Trivex System
FDA 510(k) K032387 · Smith & Nephew, Inc.
510(k) numberK032387
Submission
- Device name
- Trivex System
- Applicant
- Smith & Nephew, Inc.
Andover, MA, US - Received
- August 4, 2003
- Decision date
- October 29, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DWQ – Stripper, Vein, External
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4885
- Specialty
- Cardiovascular
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Questions and answers
When was Trivex System cleared by the FDA?
Trivex System (K032387) received a 510(k) decision of Substantially Equivalent on October 29, 2003, 86 days after the submission was received.
What is the product code of K032387?
The FDA product code is DWQ – Stripper, Vein, External, a Class II (moderate risk) device regulated under 21 CFR 870.4885.