510(k) K891588

TRI-LUMEN INTRA VASCULAR BALLOON CATHETER (GU USE) by Ideal Medical, Inc. — Product Code LQR

K891588 is an FDA 510(k) premarket notification submitted by Ideal Medical, Inc. for the device "TRI-LUMEN INTRA VASCULAR BALLOON CATHETER (GU USE)". The FDA issued a decision of Substantially Equivalent on September 28, 1989. The device falls under product code LQR (Dislodger, Stone, Biliary), a Class II device regulated under 21 CFR 876.5010. Ideal Medical, Inc. has at least 10 other 510(k) clearances on record.