Outback Ltd Re-Entry Catheter, Model: Otb42120

K083814 is the FDA 510(k) clearance record for OUTBACK LTD RE-ENTRY CATHETER, MODEL: OTB42120, a class II device, cleared for Cordis Corp., A Johnson & Johnson Co. on 2009-01-13 under FDA product code PDU (Catheter For Crossing Total Occlusions). FDA's definition for product code PDU reads: "To facilitate the intraluminal placement of conventional guidewires beyond stenotic lesions (including subchronic and chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention, such as angioplasty...". FDA records list 5 510(k) clearances for Cordis Corp., A Johnson & Johnson Co., from 2006-09-22 to 2014-11-14. As of 2026-09-10, FDA records show no recalls naming K083814.