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E-Z-Flow Angiography Catheters

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

Active United States

510(k) K890206

Overview

An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. The E-Z-Flow Angiography Catheters are included in this generic device type, which encompasses right-heart catheters, left-heart catheters, and angiographic catheters.

The device is supplied as a percutaneous catheter under product code DQO, classified as Class II with special controls. It received FDA 510(k) clearance (K890206) on May 19, 1989, following a traditional review process, and is substantially equivalent to a legally marketed predicate device.

AI-generated from registry data, 22 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 NumberK890206 Date19 May 1989ClearedStatusActive

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
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  • 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
DQO
Device Class
Class II
Regulation
21 CFR Part 870.1200
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the E-Z-Flow Angiography Catheter used for?

    The E-Z-Flow Angiography Catheter is an intravascular diagnostic device used to record intracardiac pressures, sample blood, and introduce substances into the heart and vessels. It supports diagnostic procedures involving right-heart, left-heart, and angiographic catheterization as part of its generic device type classification.

  • How is the E-Z-Flow Angiography Catheter supplied and what is its product code?

    The device is supplied as a percutaneous catheter under product code DQO. This code identifies it within the FDA’s classification system for intravascular diagnostic catheters, which are classified as Class II devices with special controls.

  • Is the E-Z-Flow Angiography Catheter sterile and intended for single use?

    While the provided data does not explicitly state sterility or single-use status, the device is supplied as a percutaneous catheter intended for intravascular use, which typically requires sterile, single-use delivery to prevent infection. Reuse would require validated reprocessing, which is not indicated in the authorization details.

  • What regulatory pathway was used for the E-Z-Flow Angiography Catheter?

    The E-Z-Flow Angiography Catheter received FDA 510(k) clearance (K890206) on May 19, 1989, through a traditional review process. It was determined to be substantially equivalent to a legally marketed predicate device, which is the standard pathway for moderate-risk Class II devices.

  • What are the manufacturer and location details for the E-Z-Flow Angiography Catheter?

    The E-Z-Flow Angiography Catheter is manufactured by E-Z-Em, Inc., located at 28 Marigold Ln., Marlboro, NJ 07746, United States. The contact person listed in the FDA record is Martin S. Knopf.