510(k) K032387
K032387 is an FDA 510(k) premarket notification submitted by Smith & Nephew, Inc. for the device "TRIVEX SYSTEM". The FDA issued a decision of Substantially Equivalent on October 29, 2003. The device falls under product code DWQ (Stripper, Vein, External), a Class II device regulated under 21 CFR 870.4885. Smith & Nephew, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 29, 2003
- Date Received
- August 4, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stripper, Vein, External
- Device Class
- Class II
- Regulation Number
- 870.4885
- Review Panel
- CV
- Submission Type