Skip to content

Arrow Endurance Extended Dwell Peripheral Catheter System

by Arrow International, Inc. (Subsidiary of Teleflex, Inc.) 2 variants

510(k) K163513

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK163513 Date24 Feb 2017ClearedStatusActive

Recalls

2 recalls · 1 ongoing · FDA

    • Ongoing Z-1826-2023 FDA Class I initiated 19 May 2023

    Potential for catheter separation or leakage

    • Terminated Z-0837-2020 FDA Class II initiated 6 Dec 2019

    Potential sterility issue for specific lots of the Arrow Endurance" Extended Dwell Peripheral Catheter System, Product Code ASK-00820-FLH.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FOZ
Device Class
Class II
Regulation
21 CFR Part 880.5200
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Other devices from Arrow International, Inc. (Subsidiary of Teleflex, Inc.)

See all devices from Arrow International, Inc. (Subsidiary of Teleflex, Inc.) →