Clearance Summary
ULTRASTREAM CHRONIC HEMODIALYSIS CATHETER received FDA 510(k) clearance under submission number K102043, sponsored by Rex Medical. The device was reviewed via the Special premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2010-11-18.
- Submission: K102043
- Applicant / Sponsor: Rex Medical
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5540
- Decision date: 2010-11-18
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.