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510(k) K243599

Arrow™ Endurance™ Extended Dwell Peripheral Catheter System (EDC-00818) by Arrow International, LLC (A subsidiary of Teleflex, Inc.) — Product Code FOZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 2025
Date Received
November 21, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Device Class
Class II
Regulation Number
880.5200
Review Panel
HO
Submission Type

Other clearances by Arrow International, LLC (A subsidiary of Teleflex, Inc.)

  • K242281 — Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00620); Arrow End (December 20, 2024)
  • K220280 — Arrow Stiffening Stylet (August 30, 2022)
  • K220363 — VPS Rhythm DLX Device with TipTracker Technology (August 22, 2022)

Other clearances for product code FOZ

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  • K252677 — Polyshield Safety IV Catheters (November 5, 2025)
  • K251422 — BD Saf-T-Intima™ Subcutaneous Catheter System (October 8, 2025)
  • K243403 — BD Nexiva™ Closed IV Catheter System (July 25, 2025)
  • K251155 — BD Cathena™ Safety IV Catheter (July 11, 2025)
  • K251654 — BD Insyte™ Autoguard™ Shielded IV Catheter, BD Insyte™ Autoguard™ BC Shielded IV (June 27, 2025)
  • K250682 — BD Nexiva™ Diffusics™ Closed IV Catheter System and BD Nexiva™ Diffusics™ Closed (June 3, 2025)
  • K243105 — Ruby Intravascular Catheter (May 16, 2025)
  • K250292 — OSPREY Midline Closed IV Catheter System (OspreyEDC-F20) (May 2, 2025)
  • K244059 — HydroMID 5F Dual Lumen Midline Catheter - Basic Kit (70006102); HydroMID 5F Dual (March 27, 2025)