510(k) K011210

THE PERCUQUICK SET FOR PERCUTANEOUS DILATION TRACHEOSTOMY by Rusch Intl. — Product Code JOH

K011210 is an FDA 510(k) premarket notification submitted by Rusch Intl. for the device "THE PERCUQUICK SET FOR PERCUTANEOUS DILATION TRACHEOSTOMY". The FDA issued a decision of Substantially Equivalent on Aug 15, 2001. The device falls under product code JOH (Tube Tracheostomy And Tube Cuff), a Class II device regulated under 21 CFR 868.5800. Rusch Intl. has at least 10 other 510(k) clearances on record.