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DeRoyal Angiography Kits

by Deroyal Industries, Inc.

510(k) K152978

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)SESK Substantially Equivalent — Kit · Traditional NumberK152978 Date25 Mar 2016ClearedStatusActive

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  • Withdrawn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
DXT
Device class
Class II
Regulation
21 CFR Part 870.1650
Advisory committee
Cardiovascular
FDA decision
SESK Substantially Equivalent — Kit

Overview

AI-generated summary, 6 Oct 2026

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

DeRoyal Angiography Kits are sterile, single-use kits assembled of medical devices to be used by medical professionals during procedures in the cardiac catheterization laboratory. The devices used in the kits are standard items for catheterization laboratory procedures such as cardiac catheterization, angiography, and arteriogram.

The kits consist of collections of legally marketed, non-sterile medical device components assembled into a single kit for use in cardiac catheterization laboratories. They are supplied sterile and for single-use only. The device has FDA 510(k) clearance with product code DXT and is classified under regulation number 870.1650.

Other devices from Deroyal Industries, Inc.

See all devices from Deroyal Industries, Inc. →

Questions

AI-generated answers, 6 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 are DeRoyal Angiography Kits used for?

    DeRoyal Angiography Kits are sterile, single-use kits containing medical devices used by professionals during procedures in cardiac catheterization laboratories, including cardiac catheterization, angiography, and arteriogram procedures.

  • Are DeRoyal Angiography Kits reusable or single-use only?

    DeRoyal Angiography Kits are supplied sterile and are designed for single-use only. They should not be reused or resterilized as this could compromise the sterility and integrity of the components.

  • What regulatory status do DeRoyal Angiography Kits have?

    DeRoyal Angiography Kits have FDA 510(k) clearance with product code DXT and are classified under regulation number 870.1650. They are legally marketed medical devices assembled from non-sterile components into sterile kits.

  • What components are included in DeRoyal Angiography Kits?

    The kits consist of collections of legally marketed, non-sterile medical device components assembled into a single kit for use in cardiac catheterization laboratories. The specific components included are standard items for catheterization laboratory procedures.