510(k) K193474

Selectra 3D Outer Guiding Catheters by Biotronik, Inc. — Product Code DQY

K193474 is an FDA 510(k) premarket notification submitted by Biotronik, Inc. for the device "Selectra 3D Outer Guiding Catheters". The FDA issued a decision of Substantially Equivalent on October 16, 2020. 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.