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Angiographic Flush System

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

Active United States

510(k) K914113

Overview

The Angiographic Flush System is a medical device classified as an Angiographic Flush Device (FDA Product Code FPA). It is designed to clear contrast media and residual blood from angiographic catheters during coronary and peripheral angiography procedures, ensuring optimal imaging quality and catheter patency. By maintaining lumen integrity, it supports accurate visualization of blood vessels and reduces the risk of clogging or obstruction during diagnostic and interventional radiology.

This system is supplied as a single-use, non-sterile device intended for use in hospital or clinical radiology settings. It is regulated under FDA 510(k) clearance (K914113) and is intended for use with angiographic catheters during coronary and peripheral angiography. The device is not MRI-compatible and must be handled according to standard aseptic practices. Storage and handling instructions are detailed in the accompanying documentation.

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

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK914113 Date22 Jan 1992ClearedStatusActive

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
FPA
Device Class
Class II
Regulation
21 CFR Part 880.5440
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the Angiographic Flush System designed for?

    The Angiographic Flush System is specifically designed to clear contrast media and residual blood from angiographic catheters during coronary and peripheral angiography procedures. This ensures optimal imaging quality by maintaining catheter lumen integrity, reducing the risk of clogging or obstruction, and supporting accurate visualization of blood vessels.

  • Is the Angiographic Flush System sterile?

    No, the Angiographic Flush System is supplied as a non-sterile device. It is intended for single-use in hospital or clinical radiology settings, so it must be handled according to standard aseptic practices to prevent contamination before use.

  • How is the Angiographic Flush System supplied?

    The device is supplied as a single-use system, meaning each unit is intended for one procedure only. This design minimizes cross-contamination risks and ensures consistent performance. The packaging includes detailed storage and handling instructions.

  • Can the Angiographic Flush System be used with any angiographic catheter?

    The Angiographic Flush System is intended for use with angiographic catheters during coronary and peripheral angiography procedures. While it is designed to be compatible with standard catheters, always verify compatibility with your specific catheter model and follow manufacturer guidelines to avoid damage or malfunction.

  • What precautions should be taken when storing or handling this device?

    Since the device is non-sterile, it must be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Follow the instructions in the accompanying documentation for proper handling, as improper storage could compromise performance or introduce contamination risks. Ensure the system remains sealed until immediately before use.