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B-D Angiographic Control Syringe

by Bd Becton Dickinson Vacutainer Systems Preanalytic 510(k)

Active United States

510(k) K895318

Overview

The B-D Angiographic Control Syringe is a Injector and Syringe, Angiographic (product code DXT), designed for precise fluid delivery during angiographic procedures. It is engineered to provide controlled injection of contrast media or other fluids with accuracy and consistency, supporting diagnostic imaging of blood vessels. The device is classified as a Class II medical device under FDA regulations, subject to special controls for cardiovascular applications.

This syringe is intended for single-use in clinical settings, including radiology departments and catheterization labs. It is supplied sterile and packaged for immediate use, requiring no additional preparation beyond standard aseptic handling. The device adheres to MRI safety standards for non-ferromagnetic materials, ensuring compatibility with magnetic resonance imaging environments. Multiple sizes and configurations are available, as indicated by the listed FEI numbers, to accommodate varying procedural requirements. FDA clearance (510(k) K895318) was granted in 1990 under the Cardiovascular advisory committee.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK895318 Date19 Jan 1990ClearedStatusActive

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
DXT
Device Class
Class II
Regulation
21 CFR Part 870.1650
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the B-D Angiographic Control Syringe used for?

    The B-D Angiographic Control Syringe is designed specifically for angiographic procedures to deliver contrast media or other fluids with precision and consistency. This ensures accurate imaging of blood vessels during diagnostic procedures in radiology departments and catheterization labs.

  • How is the B-D Angiographic Control Syringe supplied, and is it sterile?

    The syringe is supplied sterile and packaged for immediate use, requiring no additional preparation beyond standard aseptic handling. This ensures readiness for clinical procedures without extra preparation steps.

  • Is the B-D Angiographic Control Syringe single-use or reusable?

    The device is intended for single-use only. This design minimizes contamination risks and ensures patient safety by preventing reuse in multiple procedures.

  • What sizes or configurations are available for the B-D Angiographic Control Syringe?

    Multiple sizes and configurations are available, each identified by unique FEI numbers (e.g., 1000208624, 3002808086, etc.). These variations accommodate different procedural requirements, allowing clinicians to select the appropriate syringe for their specific angiographic needs.

  • Can the B-D Angiographic Control Syringe be used in MRI environments?

    Yes, the syringe adheres to MRI safety standards for non-ferromagnetic materials. This ensures compatibility with magnetic resonance imaging environments, reducing the risk of interference or complications during combined diagnostic procedures.