Selectra Catheters, Selectra Accessory Kit, Selectra Slitter Tool

About This 510(k) Submission

K192996 is an FDA 510(k) clearance for the Selectra Catheters, Selectra Accessory Kit, Selectra Slitter Tool, a Catheter, Percutaneous (Class II — Special Controls, product code DQY), submitted by Biotronik, Inc. (Lake Oswego, US). The FDA issued a Cleared decision on November 21, 2019, 24 days after receiving the submission on October 28, 2019. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.