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Arterial Catheter Mini-Kit 498435

by Argon Medical Devices, Inc.

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

2 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 Number00886333215720 UDI-DI Date20 Sep 2016ListedStatusListed GUDID: not in commercial distribution

Recalls

11 recalls · 2 ongoing · FDA

    • Ongoing Z-2708-2026 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.

    • Ongoing Z-0563-2022 FDA Class II initiated 24 Jan 2022

    Guidewire included with two lots of Arterial Line Kits would not fit through the needle of the same kit. This could potentially lead to a slight delay in the procedure and minor blood loss.

  • 2 recalls, same reason

    • Terminated Z-1937-2020 FDA Class II initiated 8 Apr 2020
    • Terminated Z-1936-2020 FDA Class II initiated 8 Apr 2020

    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.

  • 7 recalls, same reason

    • Terminated Z-1745-2010 FDA Unclassified (pre-2012) initiated 29 Mar 2010 on shared 510(k) K780871
    • Terminated Z-1743-2010 FDA Unclassified (pre-2012) initiated 29 Mar 2010 on shared 510(k) K780871
    • Terminated Z-1744-2010 FDA Unclassified (pre-2012) initiated 29 Mar 2010 on shared 510(k) K780871
    • Terminated Z-1741-2010 FDA Unclassified (pre-2012) initiated 29 Mar 2010 on shared 510(k) K780871
    • Terminated Z-1737-2010 FDA Unclassified (pre-2012) initiated 29 Mar 2010
    • Terminated Z-1742-2010 FDA Unclassified (pre-2012) initiated 29 Mar 2010 on shared 510(k) K780871
    • Terminated Z-1740-2010 FDA Unclassified (pre-2012) initiated 29 Mar 2010

    There are 1-2 places on some of the multi-purpose kit blisters/trays in which there are holes and/or the material is so thin that holes are easily created. This would potentially cause the sterility of the products to be compromised.

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
Arterial Catheter Mini-Kit
Generic Name
Angiographic catheter, single-use
Model / Ref / Catalog
498435
Primary DI / UDI-DI
00886333215720
510(k) Number
FDA Product Code
GDY
GMDN Term
Angiographic catheter, single-use
Device Class
Class I
Regulation Number
878.4450
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K780871)

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