510(k) K171988

Performer Guiding Sheath by Cook Incorporated — Product Code DYB

K171988 is an FDA 510(k) premarket notification submitted by Cook Incorporated for the device "Performer Guiding Sheath". The FDA issued a decision of Substantially Equivalent on Mar 30, 2018. 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.