510(k) K021120

RADIAL ARTERY CATHERIZATION SET WITH INTEGRAL NEEDLE PROTECTION,MODEL RA-04020-SP by Arrow Intl., Inc. — Product Code DQY

K021120 is an FDA 510(k) premarket notification submitted by Arrow Intl., Inc. for the device "RADIAL ARTERY CATHERIZATION SET WITH INTEGRAL NEEDLE PROTECTION,MODEL RA-04020-SP". The FDA issued a decision of Substantially Equivalent on May 2, 2002. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Arrow Intl., Inc. has at least 10 other 510(k) clearances on record.