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Introducer Kit w/ AMC/4 Needle 496612

by Argon Medical Devices, Inc.

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

1 ongoing

This device is named in the recall

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00886333214174 UDI-DI Date21 Sep 2016ListedStatusListed GUDID: not in commercial distribution

Recalls

5 recalls · 1 ongoing · FDA

    • Ongoing Z-2705-2026 FDA Class I initiated 1 Jun 2026

    Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.

    • Terminated Z-2806-2020 FDA Class II initiated 19 Jun 2020

    Sterile introducer sheath set manufactured under one lot with different expiration dates.

    • Terminated Z-1938-2020 FDA Class II initiated 8 Apr 2020 on shared 510(k) K780126

    Arterial Line Kits include thicker curved reverse-cutting needle with a 0-silk suture, instead of the usual straight-cutting needle with a 3-0 silk suture. The thicker suture may be more difficult to tie. The curved needle requires the use of a needle driver, there is a risk of needle stick to the surgeon tries to do it with fingers instead.

    • Terminated Z-1029-2016 FDA Class II initiated 17 Feb 2016

    The incorrect sheath was assembled to the device so that the size 7 products received 11 cm sheaths and the size 11 product received 7 cm sheaths.

    • Terminated Z-0764-2010 FDA Unclassified (pre-2012) initiated 6 Jan 2009

    One lot of Percutaneous Catheter Introducer Set contained incorrect size needle.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Introducer Kit w/ AMC/4 Needle
Generic Name
Vascular catheter introduction set, nonimplantable
Model / Ref / Catalog
496612
Primary DI / UDI-DI
00886333214174
510(k) Number
FDA Product Code
DRE
GMDN Term
Vascular catheter introduction set, nonimplantable
Device Class
Class II
Regulation Number
870.1310
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K780126)

Show all (12)

Other devices from Argon Medical Devices, Inc.

See all devices from Argon Medical Devices, Inc. →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (7)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No