510(k) K091841

BRIDGEPOINT MEDICAL CROSSBOSS CATHETER, MODEL M-2000 by Bridgepoint Medical — Product Code DQY

K091841 is an FDA 510(k) premarket notification submitted by Bridgepoint Medical for the device "BRIDGEPOINT MEDICAL CROSSBOSS CATHETER, MODEL M-2000". The FDA issued a decision of Substantially Equivalent on September 2, 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.