510(k) K070865

EXPANDING VASCULAR SHEATH by Applied Medical — Product Code DYB

K070865 is an FDA 510(k) premarket notification submitted by Applied Medical for the device "EXPANDING VASCULAR SHEATH". The FDA issued a decision of Substantially Equivalent on October 23, 2007. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Applied Medical has at least 10 other 510(k) clearances on record.