Clearance Summary
14 FR. HEMODIALYSIS TWO-LUMEN CATHETERIZATION KIT received FDA 510(k) clearance under submission number K991431, sponsored by Arrow Intl., Inc.. 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 1999-05-26.
- Submission: K991431
- Applicant / Sponsor: Arrow Intl., Inc.
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5540
- Decision date: 1999-05-26
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.