Passeo-35 Xeo Peripheral Dilatation Catheter

About This 510(k) Submission

K222065 is an FDA 510(k) clearance for the Passeo-35 Xeo Peripheral Dilatation Catheter, a Catheter, Angioplasty, Peripheral, Transluminal (Class II — Special Controls, product code LIT), submitted by Biotronik, Inc. (Lake Oswego, US). The FDA issued a Cleared decision on February 16, 2023, 218 days after receiving the submission on July 13, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.