Clearance Summary
BALLOON DILATION CATHETER received FDA 510(k) clearance under submission number K896448, sponsored by Cook Ob/Gyn. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 1990-03-07.
- Submission: K896448
- Applicant / Sponsor: Cook Ob/Gyn
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5470
- Decision date: 1990-03-07
Classification & Regulation
This clearance is catalogued under FDA product code EZN and 21 CFR 876.5470, within the Gastroenterology, Urology review panel as a Class II device.