K242281

Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00620); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00622); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00820); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00822)

510(k) number: K242281
Device name: Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00620); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00622); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00820); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00822)
Applicant: Arrow International, LLC (A subsidiary of Teleflex, Inc.) NC · US
Product code: FOZ — Catheter, Intravascular, Therapeutic, Short-Term Les
Decision date: 2024-12-20
Date received: 2024-08-02
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: General Hospital

PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain

Also available from FDA: K242281.pdf

Official FDA record: K242281

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.