510(k) K081454

GUARDDOG OCCLUSION GUIDEWIRE, INFLATION DEVICE by Possis Medical, Inc. — Product Code MJN

K081454 is an FDA 510(k) premarket notification submitted by Possis Medical, Inc. for the device "GUARDDOG OCCLUSION GUIDEWIRE, INFLATION DEVICE". The FDA issued a decision of Substantially Equivalent on June 13, 2008. The device falls under product code MJN (Catheter, Intravascular Occluding, Temporary), a Class II device regulated under 21 CFR 870.4450. Possis Medical, Inc. has at least 10 other 510(k) clearances on record.