Clearance Summary
CATHETER, TRANSLUMINAL BALLOON received FDA 510(k) clearance under submission number K781772, sponsored by Medi-Tech, Inc.. 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 1979-03-06.
- Submission: K781772
- Applicant / Sponsor: Medi-Tech, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4200
- Decision date: 1979-03-06
Classification & Regulation
This clearance is catalogued under FDA product code GBA and 21 CFR 878.4200, within the General, Plastic Surgery review panel as a Class I device.