510(k) K914088

BIVONA AIRE-CUF(R) PEDIATRIC TRACHEOSTOMY TUBE by Bivona Medical Technologies — Product Code JOH

K914088 is an FDA 510(k) premarket notification submitted by Bivona Medical Technologies for the device "BIVONA AIRE-CUF(R) PEDIATRIC TRACHEOSTOMY TUBE". The FDA issued a decision of Substantially Equivalent on October 23, 1991. The device falls under product code JOH (Tube Tracheostomy And Tube Cuff), a Class II device regulated under 21 CFR 868.5800. Bivona Medical Technologies has at least 10 other 510(k) clearances on record.