510(k) K952205

ACS POWERBASE GUILDING CATHETER by Advanced Cardiovascular Systems, Inc. — Product Code DQY

K952205 is an FDA 510(k) premarket notification submitted by Advanced Cardiovascular Systems, Inc. for the device "ACS POWERBASE GUILDING CATHETER". The FDA issued a decision of Substantially Equivalent on August 4, 1995. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Advanced Cardiovascular Systems, Inc. has at least 10 other 510(k) clearances on record.