510(k) K041453
K041453 is an FDA 510(k) premarket notification submitted by Smith & Nephew, Inc. for the device "SMITH & NEPHEW TUMESCENT CATHETER INVERSION SYSTEM, MODEL 7210023". The FDA issued a decision of Substantially Equivalent on July 22, 2004. 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
- July 22, 2004
- Date Received
- June 1, 2004
- 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