Clearance Summary
CARDICAD(TM) received FDA 510(k) clearance under submission number K881392, sponsored by Medical/Surgical Specialties, Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1988-05-31.
- Submission: K881392
- Applicant / Sponsor: Medical/Surgical Specialties, Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class I
- Regulation citation: 21 CFR 870.4500
- Decision date: 1988-05-31
Classification & Regulation
This clearance is catalogued under FDA product code DWS and 21 CFR 870.4500, within the Cardiovascular review panel as a Class I device.