Clearance Summary
SMITH & NEPHEW TUMESCENT CATHETER INVERSION SYSTEM, MODEL 7210023 received FDA 510(k) clearance under submission number K041453, sponsored by Smith & Nephew, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2004-07-22.
- Submission: K041453
- Applicant / Sponsor: Smith & Nephew, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4885
- Decision date: 2004-07-22
Classification & Regulation
This clearance is catalogued under FDA product code DWQ and 21 CFR 870.4885, within the Cardiovascular review panel as a Class II device.