510(k) K171275

Micropuncture Introducer Set, Micropuncture Introducer Set with Push-Plus Design, Micropuncture Introducer Set with Silhouette Transitionless Design, Micropuncture Introducer Set with Silhouette Transitionless Design and Push-Plus Design by Cook Incorporated — Product Code DYB

K171275 is an FDA 510(k) premarket notification submitted by Cook Incorporated for the device "Micropuncture Introducer Set, Micropuncture Introducer Set with Push-Plus Design, Micropuncture Introducer Set with Silhouette Transitionless Design, Micropuncture Introducer Set with Silhouette Transitionless Design and Push-Plus Design". The FDA issued a decision of Substantially Equivalent - Kit on Dec 20, 2017. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Cook Incorporated has 174 other 510(k) clearances on record.