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Cathode Powder Specification Change

by Telectronics and Cordis Pacing Systems

510(k) K881904

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 NumberK881904 Date22 Jul 1988ClearedStatusActive

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  • Withdrawn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)

Full name
Change to Cathode Powder Specification
510(k) Number
FDA Product Code
DXY
Device Class
Class III
Regulation
21 CFR Part 870.3610
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

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

This device is a specification change for an Implantable Pacemaker Pulse-Generator, as classified under FDA product code DXY. It pertains to modifications in the cathode powder formulation used within implantable pacemaker systems, ensuring compatibility with existing pulse-generator designs while maintaining electrical performance and longevity.

The Cathode Powder Specification Change is a pre-market notification (510(k)) submission filed under the FDA’s traditional review pathway for Class III devices, with clearance granted on July 22, 1988 (K881904). It applies to implantable pacemakers and does not involve changes to device sterility, single-use, or MRI safety. The modification is administrative, reflecting updates to material specifications rather than structural or functional alterations. No additional regulatory approvals beyond the 510(k) clearance are indicated.

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