Clearance Summary
EXTERNAL COUNTERPULSATION (ECP) MODEL US-ECP received FDA 510(k) clearance under submission number K030587, sponsored by S-Tct Health, 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 2003-05-30.
- Submission: K030587
- Applicant / Sponsor: S-Tct Health, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.5225
- Decision date: 2003-05-30
Classification & Regulation
This clearance is catalogued under FDA product code DRN and 21 CFR 870.5225, within the Cardiovascular review panel as a Class II device.