510(k) K891021

TRI-LUMEN INTRA VASCULAR BALLOON CATHETER by Ideal Medical, Inc. — Product Code DXE

K891021 is an FDA 510(k) premarket notification submitted by Ideal Medical, Inc. for the device "TRI-LUMEN INTRA VASCULAR BALLOON CATHETER". The FDA issued a decision of Substantially Equivalent on September 18, 1989. The device falls under product code DXE (Catheter, Embolectomy), a Class II device regulated under 21 CFR 870.5150. Ideal Medical, Inc. has at least 10 other 510(k) clearances on record.