510(k) K220280

Arrow Stiffening Stylet by Arrow International, LLC (A subsidiary of Teleflex, Inc.) — Product Code DRB

K220280 is an FDA 510(k) premarket notification submitted by Arrow International, LLC (A subsidiary of Teleflex, Inc.) for the device "Arrow Stiffening Stylet". The FDA issued a decision of Substantially Equivalent on August 30, 2022. The device falls under product code DRB (Stylet, Catheter), a Class II device regulated under 21 CFR 870.1380. Arrow International, LLC (A subsidiary of Teleflex, Inc.) has at least 3 other 510(k) clearances on record.