510(k) K022880

GUIDANT PROXIMAL SEAL SYSTEM, MODELS PSS-4500 & PS-4500 by Guidant Corp. — Product Code DXC

K022880 is an FDA 510(k) premarket notification submitted by Guidant Corp. for the device "GUIDANT PROXIMAL SEAL SYSTEM, MODELS PSS-4500 & PS-4500". The FDA issued a decision of Substantially Equivalent on September 13, 2002. The device falls under product code DXC (Clamp, Vascular), a Class II device regulated under 21 CFR 870.4450. Guidant Corp. has at least 10 other 510(k) clearances on record.