Clearance Summary
SCD EXPRESS PORTABLE COMPRESSION SYSTEM received FDA 510(k) clearance under submission number K040511, sponsored by Tyco Healthcare/Kendall. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2004-06-28.
- Submission: K040511
- Applicant / Sponsor: Tyco Healthcare/Kendall
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.5800
- Decision date: 2004-06-28
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.