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Cook 331T Unipolar Cardiac Pulse Generator W/Telem

by Cook Pacemaker Corp.

510(k) K850656

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 NumberK850656 Date1 Mar 1985ClearedStatusActive

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  • Withdrawn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
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 331T Unipolar Cardiac Pulse Generator with Telem is an Implantable Pacemaker Pulse-Generator, designed to regulate cardiac rhythm by delivering electrical impulses to the heart. It operates as a unipolar system, utilizing a single electrode lead for pacing, and includes telemetry capabilities for remote monitoring and data transmission.

This device is intended for implantable use within the cardiovascular setting and is classified as a Class III medical device under FDA regulations. Supplied sterile and intended for single-use, it requires surgical implantation and is regulated under FDA 510(k) clearance (K850656). Compliance with 21 CFR 870.3610 ensures adherence to implantable cardiac device standards, with no indication of MRI compatibility or reusable components.

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