510(k) K210627

Breezeway II by Oscor, Inc. — Product Code DYB

K210627 is an FDA 510(k) premarket notification submitted by Oscor, Inc. for the device "Breezeway II". The FDA issued a decision of Substantially Equivalent on June 3, 2021. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Oscor, Inc. has at least 10 other 510(k) clearances on record.