Clearance Summary
TERUMO ANGIOGRAPHIC CATHETER FOR LAPOROSCOPIC USE received FDA 510(k) clearance under submission number K926217, sponsored by Terumo Medical Corp.. 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 1993-07-13.
- Submission: K926217
- Applicant / Sponsor: Terumo Medical Corp.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4200
- Decision date: 1993-07-13
Classification & Regulation
This clearance is catalogued under FDA product code GBZ and 21 CFR 878.4200, within the General, Plastic Surgery review panel as a Class I device.