Needles Used in Angiographic Proced.

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K772369 ↗

FDA Product Code

DRC

Device Class

Class II

Regulation

21 CFR Part 870.1390

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 are these needles used for in angiographic procedures?

  These needles are specifically designed for vascular access during diagnostic and interventional cardiovascular imaging. They enable the insertion of catheters and guidewires into arteries, allowing for contrast injection and real-time visualization of blood vessels. Their precision and reliability help ensure procedural success while minimizing trauma to the patient.

• Are these needles single-use or reusable?

  These needles are supplied as sterile, single-use devices. This design ensures patient safety by preventing cross-contamination and maintaining sterility for each procedure, which is critical in controlled clinical environments like catheterization labs.

• What gauge and length variants are available?

  Multiple gauge and length variants are available to ensure compatibility with standard guidewire systems. The exact specifications should be referenced in the manufacturer’s documentation, as these variations allow clinicians to select the appropriate needle for different patient anatomies and procedural requirements.

• How should these needles be stored to maintain sterility?

  Storage must adhere strictly to the manufacturer’s guidelines to preserve sterility and functionality. This typically includes keeping the needles in their original, sealed packaging away from direct light, moisture, and extreme temperatures until use. Proper storage ensures the device remains effective for its intended single-use application.

• Are these needles FDA-cleared, and what pathway was used?

  Yes, these needles are FDA-cleared as Class II medical devices under product code DRC. They were cleared via a Traditional 510(k) pathway in 1978, demonstrating substantial equivalence to a predicate device. The clearance reflects their compliance with FDA regulations for use in angiographic procedures.