510(k) K180034

Weinmann Tracheostomy Exchange Set by Cook Incorporated — Product Code JOH

K180034 is an FDA 510(k) premarket notification submitted by Cook Incorporated for the device "Weinmann Tracheostomy Exchange Set". The FDA issued a decision of Substantially Equivalent on May 7, 2018. The device falls under product code JOH (Tube Tracheostomy And Tube Cuff), a Class II device regulated under 21 CFR 868.5800. Cook Incorporated has at least 10 other 510(k) clearances on record.