510(k) K183265

Selectra Catheters, Selectra Accessory Kit by Biotronik, Inc. — Product Code DQY

K183265 is an FDA 510(k) premarket notification submitted by Biotronik, Inc. for the device "Selectra Catheters, Selectra Accessory Kit". The FDA issued a decision of Substantially Equivalent on December 13, 2018. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Biotronik, Inc. has at least 10 other 510(k) clearances on record.