Clearance Summary
PTC-6 AND PTC-8 PERCUTANEOUS CHOLANGIOGRAPHY received FDA 510(k) clearance under submission number K870420, sponsored by North Coast Medi-Tek. 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 1987-04-14.
- Submission: K870420
- Applicant / Sponsor: North Coast Medi-Tek
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4200
- Decision date: 1987-04-14
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.