Clearance Summary
ELECTRODE, TEMPORARY MYOCARDIAL received FDA 510(k) clearance under submission number K760513, sponsored by Winn Hirsch & Assoc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1976-10-15.
- Submission: K760513
- Applicant / Sponsor: Winn Hirsch & Assoc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class III
- Regulation citation: 21 CFR 870.3680
- Decision date: 1976-10-15
Classification & Regulation
This clearance is catalogued under FDA product code DTB and 21 CFR 870.3680, within the Cardiovascular review panel as a Class III device.