Clearance Summary
TRI-LUMEN INTRA VASCULAR BALLOON CATHETER (GU USE) received FDA 510(k) clearance under submission number K891588, sponsored by Ideal Medical, Inc.. 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 1989-09-28.
- Submission: K891588
- Applicant / Sponsor: Ideal Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5010
- Decision date: 1989-09-28
Classification & Regulation
This clearance is catalogued under FDA product code LQR and 21 CFR 876.5010, within the Gastroenterology, Urology review panel as a Class II device.