510(k) K021723

SHEATH ADAPTER, MODEL SA-09847 by Arrow Intl., Inc. — Product Code DYB

K021723 is an FDA 510(k) premarket notification submitted by Arrow Intl., Inc. for the device "SHEATH ADAPTER, MODEL SA-09847". The FDA issued a decision of Substantially Equivalent on August 8, 2002. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Arrow Intl., Inc. has at least 10 other 510(k) clearances on record.