Clearance Summary
CARDIO-BAND received FDA 510(k) clearance under submission number K813566, sponsored by Cardio-Band, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1982-02-22.
- Submission: K813566
- Applicant / Sponsor: Cardio-Band, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class:
- Decision date: 1982-02-22
Classification & Regulation
This clearance is catalogued under FDA product code LDQ , within the General Hospital review panel as a device.