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Cook #326T Program/Telemetry Bipolar Implantable Pacemaker Pulse-Generator

by Cook Pacemaker Corp.

510(k) K821147

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 NumberK821147 Date7 May 1982ClearedStatusActive

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  • Withdrawn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
Cook #326T Program/Telemetry Bipolar
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.

The Cook #326T Program/Telemetry Bipolar is an implantable pacemaker pulse-generator designed to regulate cardiac rhythm in patients with bradycardia or conduction disorders. This device delivers electrical impulses to stimulate the heart muscle, ensuring proper pacing and maintaining normal heart function through bipolar electrode configuration for precise energy delivery.

This device is intended for surgical implantation and is classified as a Class III medical device under FDA regulations (DXY, 870.3610). It is supplied sterile and intended for single-use, with telemetry capabilities for remote programming and monitoring. The device is authorized under an FDA 510(k) clearance (K821147) and is regulated within the cardiovascular specialty, adhering to strict manufacturing and performance standards for implantable cardiac devices.

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