Clearance Summary
Pristine Hemodialysis Catheter received FDA 510(k) clearance under submission number K182443, sponsored by Pristine Access Technologies , Ltd.. 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 2019-05-31.
- Submission: K182443
- Applicant / Sponsor: Pristine Access Technologies , Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5540
- Decision date: 2019-05-31
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.