510(k) K834074

PERCUTANEOUS SHEATH INTRODUCER TRAY by Packaging Technologies, Inc. — Product Code DYB

K834074 is an FDA 510(k) premarket notification submitted by Packaging Technologies, Inc. for the device "PERCUTANEOUS SHEATH INTRODUCER TRAY". The FDA issued a decision of Substantially Equivalent on March 19, 1984. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Packaging Technologies, Inc. has at least 10 other 510(k) clearances on record.