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Modified Argyle Polyurethane Umbilical Vessel Catheter 2.5Fr, 3.5Fr, 5 Fr.

by Covidien Lp, Formerly Registered AS Kendall

510(k) K130725

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

3 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 NumberK130725 Date17 Apr 2013ClearedStatusActive

Recalls

3 recalls · 3 ongoing · FDA

  • 3 recalls, same reason

    • Ongoing Z-1872-2025 FDA Class II initiated 2 May 2025
    • Ongoing Z-1871-2025 FDA Class II initiated 2 May 2025
    • Ongoing Z-1873-2025 FDA Class II initiated 2 May 2025

    Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.

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  • Withdrawn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
FOS
Device Class
Class II
Regulation
21 CFR Part 880.5200
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

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