510(k) K220363

VPS Rhythm DLX Device with TipTracker Technology by Arrow International, LLC (A subsidiary of Teleflex, Inc.) — Product Code LJS

K220363 is an FDA 510(k) premarket notification submitted by Arrow International, LLC (A subsidiary of Teleflex, Inc.) for the device "VPS Rhythm DLX Device with TipTracker Technology". The FDA issued a decision of Substantially Equivalent on August 22, 2022. The device falls under product code LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days), a Class II device regulated under 21 CFR 880.5970. Arrow International, LLC (A subsidiary of Teleflex, Inc.) has at least 3 other 510(k) clearances on record.