510(k) K252766

14Fr Low Profile Introducer Kit by Abiomed, Inc. — Product Code DYB

K252766 is an FDA 510(k) premarket notification submitted by Abiomed, Inc. for the device "14Fr Low Profile Introducer Kit". The FDA issued a decision of Substantially Equivalent on October 8, 2025. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Abiomed, Inc. has at least 10 other 510(k) clearances on record.