510(k) K081130

BRIDGEPOINT MEDICAL CROSSBOSS PERCUTANEOUS CORONARY CATHETER by Bridgepoint Medical — Product Code DQY

K081130 is an FDA 510(k) premarket notification submitted by Bridgepoint Medical for the device "BRIDGEPOINT MEDICAL CROSSBOSS PERCUTANEOUS CORONARY CATHETER". The FDA issued a decision of Substantially Equivalent on May 14, 2009. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Bridgepoint Medical has at least 10 other 510(k) clearances on record.