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Mahurkar Triple Lumen Dialysis Catheter

by Covidien, LLC, Formerly Registered AS Tyco Healthca

510(k) K102605

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

25 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 12 Oct 2026. What this means

Regulatory status

as of registry sync 12 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESK Substantially Equivalent — Kit · Traditional NumberK102605 Date22 Dec 2010ClearedStatusActive

Recalls

26 recalls · 25 ongoing · FDA

  • 25 recalls, same reason

    • Ongoing Z-2367-2023 FDA Class I initiated 28 Jun 2023
    • Ongoing Z-2389-2023 FDA Class I initiated 28 Jun 2023
    • Ongoing Z-2376-2023 FDA Class I initiated 28 Jun 2023
    • Ongoing Z-2372-2023 FDA Class I initiated 28 Jun 2023
    • Ongoing Z-2385-2023 FDA Class I initiated 28 Jun 2023
    • Ongoing Z-2370-2023 FDA Class I initiated 28 Jun 2023
    • Ongoing Z-2383-2023 FDA Class I initiated 28 Jun 2023
    • Ongoing Z-2369-2023 FDA Class I initiated 28 Jun 2023
    • Ongoing Z-2381-2023 FDA Class I initiated 28 Jun 2023
    • Ongoing Z-2382-2023 FDA Class I initiated 28 Jun 2023
    • Ongoing Z-2373-2023 FDA Class I initiated 28 Jun 2023
    • Ongoing Z-2386-2023 FDA Class I initiated 28 Jun 2023
    • Ongoing Z-2374-2023 FDA Class I initiated 28 Jun 2023
    • Ongoing Z-2375-2023 FDA Class I initiated 28 Jun 2023
    • Ongoing Z-2368-2023 FDA Class I initiated 28 Jun 2023
    • Ongoing Z-2387-2023 FDA Class I initiated 28 Jun 2023
    • Ongoing Z-2388-2023 FDA Class I initiated 28 Jun 2023
    • Ongoing Z-2391-2023 FDA Class I initiated 28 Jun 2023
    • Ongoing Z-2371-2023 FDA Class I initiated 28 Jun 2023
    • Ongoing Z-2390-2023 FDA Class I initiated 28 Jun 2023
    • Ongoing Z-2380-2023 FDA Class I initiated 28 Jun 2023
    • Ongoing Z-2378-2023 FDA Class I initiated 28 Jun 2023
    • Ongoing Z-2384-2023 FDA Class I initiated 28 Jun 2023
    • Ongoing Z-2379-2023 FDA Class I initiated 28 Jun 2023
    • Ongoing Z-2377-2023 FDA Class I initiated 28 Jun 2023

    Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, partially or fully, and/or uncured or excessive MDX may dislodge from the catheter lead to full catheter obstruction resulting in delay to treatment and partial obstruction resulting in reduced flow, or particulate dislodgement that may result in delay to treatment, hemolysis, embolism/embolus or thrombosis/thrombus

    • Terminated Z-1955-2019 FDA Class II initiated 29 Apr 2019

    The priming volume values printed on the MAHURKA and Argyle acute catheters and Instructions for Use (IFU) are higher than the volumes required to fill each lumen.

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
NIE
Device Class
Class II
Regulation
21 CFR Part 876.5540
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESK Substantially Equivalent — Kit

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