Clearance Summary
Pristine Long-Term Hemodialysis Catheter received FDA 510(k) clearance under submission number K203767, sponsored by C B Bard, 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 2021-04-02.
- Submission: K203767
- Applicant / Sponsor: C B Bard, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5540
- Decision date: 2021-04-02
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.