Clearance Summary
IMPACT BALLOON DILATION CATHETER received FDA 510(k) clearance under submission number K983373, sponsored by B. Braun/Mcgaw. 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 1999-06-22.
- Submission: K983373
- Applicant / Sponsor: B. Braun/Mcgaw
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5365
- Decision date: 1999-06-22
Classification & Regulation
This clearance is catalogued under FDA product code KNQ and 21 CFR 876.5365, within the Gastroenterology, Urology review panel as a Class II device.