510(k) K093050

ARROW SELDINGER ARTERIAL CATHERIZATION DEVICES, MODELS EX SAC 00520 by Arrow Intl., Inc. — Product Code DQY

K093050 is an FDA 510(k) premarket notification submitted by Arrow Intl., Inc. for the device "ARROW SELDINGER ARTERIAL CATHERIZATION DEVICES, MODELS EX SAC 00520". The FDA issued a decision of Substantially Equivalent on December 18, 2009. 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.