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One-Piece/Tuohy-Borst Catheter Introducer Kit A497444

by Argon Medical Devices, Inc.

Active European Union. Also listed in GUDID (US), not in commercial distribution.

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

1 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

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

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00886333216413 UDI-DI Date12 Sep 2016ListedStatusListed GUDID: not in commercial distribution
European UnionCE/MDD EUDAMED Number— Date—StatusActive

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

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
One-Piece/Tuohy-Borst Catheter Introducer Kit
Generic Name
Vascular catheter introduction set, nonimplantable
Model / Ref / Catalog
A497444
Primary DI / UDI-DI
00886333216413
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