Clearance Summary
LOW PRESSURE TAMPONADE BALLOON CATHETER received FDA 510(k) clearance under submission number K941012, sponsored by Applied Medical Resources. 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 1994-04-18.
- Submission: K941012
- Applicant / Sponsor: Applied Medical Resources
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5130
- Decision date: 1994-04-18
Classification & Regulation
This clearance is catalogued under FDA product code EYB and 21 CFR 876.5130, within the Gastroenterology, Urology review panel as a Class II device.