Clearance Summary
LONG-TERM HEMODIALYSIS CATHETERS WITH BIOBLOC COATING received FDA 510(k) clearance under submission number K053589, sponsored by Bard Access Systems, 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 2006-04-13.
- Submission: K053589
- Applicant / Sponsor: Bard Access Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5540
- Decision date: 2006-04-13
Classification & Regulation
This clearance is catalogued under FDA product code MSD and 21 CFR 876.5540, within the Gastroenterology, Urology review panel as a Class II device.