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Evert-O-Cath Catheter

by American Biomaterials Corp.

510(k) K922455

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK922455 Date7 Jul 1994ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

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

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Evert-O-Cath Catheter is a diagnostic intravascular catheter designed for cardiovascular use. It is classified under the product code DQO and falls within the category of catheters intended for intravascular diagnostic procedures. This device is intended for insertion into blood vessels to facilitate diagnostic imaging or interventions within the cardiovascular system.

The Evert-O-Cath Catheter is supplied by American Biomaterials Corp. and has received FDA 510(k) clearance under the traditional review pathway, classified as substantially equivalent (SESE) with a decision date of July 7, 1994. It is intended for single-use applications, as implied by its classification and regulatory submission. No specific sterility or MRI safety information is provided in the available data, but it adheres to regulatory standards for intravascular diagnostic catheters.

Other devices from American Biomaterials Corp.

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Evert-O-Cath Catheter used for?

    The Evert-O-Cath Catheter is designed for intravascular diagnostic procedures within the cardiovascular system. It is inserted into blood vessels to enable diagnostic imaging or interventions, such as angiography or other diagnostic evaluations, ensuring accurate assessment of the cardiovascular anatomy and function.

  • Is the Evert-O-Cath Catheter intended for single-use or reuse?

    The Evert-O-Cath Catheter is intended for single-use applications. This classification aligns with regulatory standards for intravascular diagnostic catheters and is implied by its FDA 510(k) submission and intended use in sterile medical procedures.

  • What regulatory pathway did the Evert-O-Cath Catheter follow for FDA clearance?

    The Evert-O-Cath Catheter received FDA 510(k) clearance through the traditional review pathway. It was classified as substantially equivalent (SESE) to a predicate device, with a decision date of July 7, 1994, under product code DQO for intravascular diagnostic catheters.

  • Does the Evert-O-Cath Catheter come with specific sterility information?

    The available data does not explicitly state whether the Evert-O-Cath Catheter is sterile upon packaging. However, as a single-use medical device intended for intravascular procedures, it is expected to adhere to standard sterility requirements for such devices, ensuring safety for diagnostic use.

  • Who manufactures and distributes the Evert-O-Cath Catheter?

    The Evert-O-Cath Catheter is manufactured and supplied by American Biomaterials Corp., based in The Woodlands, Texas. For inquiries, contact information is available through their listed address and contact person, Joyce Heinrich.