510(k) K073041

RELIEVA AND RELIEVA ACELLA SINUS BALLOON CATHETER by Acclarent, Inc. — Product Code KAM

K073041 is an FDA 510(k) premarket notification submitted by Acclarent, Inc. for the device "RELIEVA AND RELIEVA ACELLA SINUS BALLOON CATHETER". The FDA issued a decision of Substantially Equivalent on March 11, 2008. The device falls under product code KAM (Cannula, Sinus), a Class I device regulated under 21 CFR 878.4800. Acclarent, Inc. has at least 10 other 510(k) clearances on record.