Clearance Summary
KEYSTONE MEDICAL SCHON XL SOFT-LINE DOUBLE LUMENT CATHETER. KEYSTONE MEDICAL 12 F DUO-FLOW AND 14F DUO-FLOW 400 XL CATH received FDA 510(k) clearance under submission number K001958, sponsored by Keystone Medical. 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 2000-09-25.
- Submission: K001958
- Applicant / Sponsor: Keystone Medical
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5540
- Decision date: 2000-09-25
Classification & Regulation
This clearance is catalogued under FDA product code MPB and 21 CFR 876.5540, within the Gastroenterology, Urology review panel as a Class II device.