Skip to content

Cordis Pacemaker Programmers 255A & 256A

by Cordis Corp.

510(k) K810552

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 NumberK810552 Date20 Mar 1981ClearedStatusActive

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  • Withdrawn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
KRG
Device class
Class III
Regulation
21 CFR Part 870.3700
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.

The Cordis Pacemaker Programmers 255A & 256A are external devices designed for programming and configuring implantable pacemakers. These programmers facilitate adjustments to pacing parameters, such as heart rate, timing intervals, and output levels, ensuring optimal cardiac function for patients with bradycardia or other pacemaker-dependent conditions.

These devices are intended for use in clinical settings by trained healthcare professionals, typically in cardiac electrophysiology labs or hospital electrophysiology units. Supplied as reusable medical equipment, they comply with FDA 510(k) clearance under product code KRG and regulation 870.3700, with a decision classification of Substantially Equivalent (SESE). Storage and handling follow standard medical device protocols to maintain functionality and sterility where applicable.

Other devices from Cordis US Corp.

See all devices from Cordis US Corp. →