Passeo-14 Peripheral Dilatation Catheter

About This 510(k) Submission

K152240 is an FDA 510(k) clearance for the Passeo-14 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 October 8, 2015, 59 days after receiving the submission on August 10, 2015. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.