Clearance Summary
KENDALL SCD EXPRESS KAMBIA THIGH LENGTH TEARAWAY SLEEVE received FDA 510(k) clearance under submission number K040649, sponsored by Tyco Healthcare. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2004-07-15.
- Submission: K040649
- Applicant / Sponsor: Tyco Healthcare
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.5800
- Decision date: 2004-07-15
Classification & Regulation
This clearance is catalogued under FDA product code JOW and 21 CFR 870.5800, within the Cardiovascular review panel as a Class II device.