Dilator, Vessel & Introducer, Sheath

• • 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.

510(k) Number

K780126 ↗

FDA Product Code

DRE

Device Class

Class II

Regulation

21 CFR Part 870.1310

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• V-Stick Vascular Access Set

  Class II

  FDA 510(k) K130730 Active Cleared 22 Nov 2013

• Digicath

  Class II

  FDA 510(k) K831171 Active Cleared 25 May 1983

• Central Catheter Kit

  Class II

  FDA 510(k) K780673 Active Cleared 16 May 1978

• Argon Dual Lumen Hemodialysis, Catheter

  Class II

  FDA 510(k) K842039 Active Cleared 29 Jan 1985

• Translumbar Aortography Needle Catheter

  Class II

  FDA 510(k) K884375 Active Cleared 11 Jan 1989

• Introducer for Ptca Guiding Catheters

  Class II

  FDA 510(k) K891022 Active Cleared 19 May 1989

See all devices from Argon Medical Corp. →

• What is the primary purpose of this dilator, vessel & introducer sheath in clinical practice?

  This device is designed to facilitate vascular access during percutaneous catheterization procedures. It acts as a sheath introducer, allowing healthcare providers to insert guidewires and catheters into blood vessels while minimizing trauma to the vessel walls. This is particularly useful in cardiovascular applications where precise and gentle access is critical.

• Is this device intended for single-use or can it be reused?

  The device is supplied as a single-use component within a Custom Procedure Set (CPS), though the reusable component itself may refer to other parts of the set. The dilator, vessel & introducer sheath itself is not explicitly stated as reusable in the provided data, so it should be treated as intended for single-use to ensure sterility and safety.

• What regulatory pathway was followed for this device’s approval, and what does that mean for its use?

  This device was authorized through the FDA’s 510(k) clearance process, specifically under the traditional pathway with a decision of 'Substantially Equivalent' (SESE). It is classified under Class II with Special Controls and is intended for cardiovascular applications, adhering to regulatory standards for percutaneous catheterization. This means it has undergone evaluation to demonstrate safety and effectiveness compared to a predicate device.

• How is this device supplied, and what should clinicians expect when ordering it?

  The device is supplied as part of a Custom Procedure Set (CPS), which includes the dilator, vessel & introducer sheath as a single-use component. Clinicians should expect to receive a pre-packaged set designed for specific procedural needs, ensuring compatibility and ease of use during interventional cardiovascular procedures.

• Are there different sizes or models available for this device, and how would a clinician determine the appropriate one?

  The provided data does not specify exact sizes or models of the dilator, vessel & introducer sheath, but it is classified under product code DRE for percutaneous catheterization. Clinicians should refer to the manufacturer’s documentation or consult with Argon Medical Corp. to select the appropriate size or model based on the patient’s anatomy and procedural requirements, as these details are not explicitly listed in the regulatory data.