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Arrow Endurance Extended Dwell Peripheral Catheter System

by Arrow Internation, Inc. (Subsidiary of Teleflex Inc.)

510(k) K151513

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

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 · Traditional NumberK151513 Date8 Jul 2015ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1194-2018 FDA Class II initiated 15 Dec 2017

    Certain lots of peripheral catheter systems may be missing the safety latch, intended to minimize the risk of sharps injuries.

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  • Withdrawn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