510(k) K221397

MitraClip G4 Steerable Guide Catheter by ABBOTT MEDICAL — Product Code DRA

K221397 is an FDA 510(k) premarket notification submitted by ABBOTT MEDICAL for the device "MitraClip G4 Steerable Guide Catheter". The FDA issued a decision of Substantially Equivalent on September 28, 2022. The device falls under product code DRA (Catheter, Steerable), a Class II device regulated under 21 CFR 870.1280. ABBOTT MEDICAL has at least 10 other 510(k) clearances on record.