Clearance Summary
OPER. TABLE FOR PERCUTAN. TRANS. CORONARY ANGIO. received FDA 510(k) clearance under submission number K883613, sponsored by Stierlen-Maquet AG. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 1988-09-15.
- Submission: K883613
- Applicant / Sponsor: Stierlen-Maquet AG
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4960
- Decision date: 1988-09-15
Classification & Regulation
This clearance is catalogued under FDA product code GDC and 21 CFR 878.4960, within the General, Plastic Surgery review panel as a Class I device.