510(k) K882289

ARIES 40CC PERCU. (D/L) INTRA-AORTIC BALLOON CATH. by Aries Medical, Inc. — Product Code DSY

K882289 is an FDA 510(k) premarket notification submitted by Aries Medical, Inc. for the device "ARIES 40CC PERCU. (D/L) INTRA-AORTIC BALLOON CATH.". The FDA issued a decision of Substantially Equivalent on December 12, 1988. The device falls under product code DSY (Prosthesis, Vascular Graft, Of 6mm And Greater Diameter), a Class II device regulated under 21 CFR 870.3450. Aries Medical, Inc. has at least 10 other 510(k) clearances on record.