Selectra Catheters and Selectra Accessory Kit

About This 510(k) Submission

K151409 is an FDA 510(k) clearance for the Selectra Catheters and Selectra Accessory Kit, a Catheter, Percutaneous (Class II — Special Controls, product code DQY), submitted by Biotronik, Inc. (Lake Oswego, US). The FDA issued a Cleared decision on August 7, 2015, 73 days after receiving the submission on May 26, 2015. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.