Huber Needle Infusion Set, Safety Huber Needle Infusion Set

K200463 is the FDA 510(k) clearance record for Huber Needle Infusion Set, Safety Huber Needle Infusion Set, a class II device, cleared for Jiangsu Caina Medical Co.,Ltd on 2021-04-07 under FDA product code PTI (Non-Coring (Huber) Needle). FDA's definition for product code PTI reads: "The non-coring needle (Huber) is utilized to gain access into a subcutaneous implanted intravascular infusion port but can also be used to access other non-vascular implanted devices with similar septums". FDA records list 15 510(k) clearances for Jiangsu Caina Medical Co.,Ltd, from 2018-06-14 to 2024-03-07. As of 2026-09-10, FDA records show no recalls naming K200463.