510(k) K190525

RELIEVA ULTIRRA Sinus Balloon Catheter by Acclarent, Inc. — Product Code LRC

K190525 is an FDA 510(k) premarket notification submitted by Acclarent, Inc. for the device "RELIEVA ULTIRRA Sinus Balloon Catheter". The FDA issued a decision of Substantially Equivalent on May 3, 2019. The device falls under product code LRC (Instrument, Ent Manual Surgical), a Class I device regulated under 21 CFR 874.4420. Acclarent, Inc. has at least 10 other 510(k) clearances on record.