Clearance Summary
Multi-Lumen Acute Hemodialysis Catheter for High Volume Infusions received FDA 510(k) clearance under submission number K143102, sponsored by Arrow International, Inc. (Subsidiary of Teleflex, 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 2015-07-24.
- Submission: K143102
- Applicant / Sponsor: Arrow International, Inc. (Subsidiary of Teleflex, Inc.)
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5540
- Decision date: 2015-07-24
Classification & Regulation
This clearance is catalogued under FDA product code NIE and 21 CFR 876.5540, within the Gastroenterology, Urology review panel as a Class II device.