Skip to content

Disposable Angiography Needle, Modification

by E-Z-Em, Inc. 510(k)

Active United States

510(k) K914985

Overview

The Disposable Angiography Needle, Modification is a single-use, sterile trocar designed for vascular access procedures. It is intended for use in angiography, facilitating the insertion of catheters into blood vessels for diagnostic or therapeutic interventions.

This device is supplied as a disposable, non-reusable item and is classified under FDA product code DRC as a Class II medical device under special controls. It is intended for use in controlled clinical settings, such as catheterization laboratories, and requires adherence to standard sterile procedures. The device received FDA 510(k) clearance in 1991 under the K914985 submission.

AI-generated from registry data, 19 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK914985 Date20 Dec 1991ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
DRC
Device Class
Class II
Regulation
21 CFR Part 870.1390
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Other devices from E-Z-Em, Inc.

See all devices from E-Z-Em, Inc. →

Questions

  • What is the primary use of the Disposable Angiography Needle, Modification in clinical settings?

    The Disposable Angiography Needle, Modification is specifically designed for vascular access procedures during angiography. It facilitates the insertion of catheters into blood vessels, enabling both diagnostic imaging and therapeutic interventions in controlled clinical settings like catheterization laboratories.

  • Is this device intended for reuse, or is it meant to be used only once?

    This device is explicitly labeled as a single-use item. It is not intended for reuse, and the manufacturer supplies it as a disposable to ensure sterility and safety for each procedure.

  • What type of sterility assurance is provided with the Disposable Angiography Needle, Modification?

    The device is supplied in a sterile condition, as required for vascular access procedures. Sterility is a critical feature to prevent infection during angiography, and the packaging ensures it remains uncontaminated until use.

  • How is this device categorized under FDA regulations, and what does that mean for its use?

    The Disposable Angiography Needle, Modification is classified as a Class II medical device under FDA product code DRC, subject to special controls. This classification indicates it requires compliance with additional safety and performance standards beyond general controls, ensuring its safe use in controlled clinical environments like catheterization labs.

  • What should clinicians consider regarding storage and handling of this device?

    Since the device is sterile and single-use, clinicians must store it in its original, unopened packaging to maintain sterility until immediate use. Proper handling—such as avoiding contamination and adhering to sterile procedure protocols—is essential to prevent complications during angiography.