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Cardiac Pacer Model 208

by Cordis Corp.

510(k) K780066

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 NumberK780066 Date30 Jan 1978ClearedStatusActive

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  • Withdrawn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 Cardiac Pacer Model 208 is an Implantable Pacemaker Pulse-Generator, classified under product code DXY. This device is designed to regulate abnormal heart rhythms by delivering electrical impulses to maintain proper cardiac pacing, ensuring consistent and effective heart function for patients with bradycardia or conduction disorders.

This device is intended for implantable use within the cardiovascular system and has received FDA 510(k) clearance under the traditional review pathway. As a Class III device, it falls under strict regulatory oversight due to its life-sustaining nature. Supplied sterile and intended for single-use implantation, it requires surgical placement and is regulated under FDA regulation number 870.3610 for pacemaker pulse-generators.

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Questions

AI-generated answers, 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.

  • What is the primary purpose of the Cardiac Pacer Model 208, and how does it function in patients?

    The Cardiac Pacer Model 208 is designed to regulate abnormal heart rhythms by delivering electrical impulses to maintain proper cardiac pacing. It is specifically intended for patients with bradycardia or conduction disorders, ensuring consistent and effective heart function through implantable use within the cardiovascular system.

  • Is the Cardiac Pacer Model 208 intended for single-use or reusable applications, and how should it be handled post-implantation?

    The Cardiac Pacer Model 208 is supplied sterile and intended for single-use implantation only. After surgical placement, it is not designed for reuse, and proper disposal procedures should follow medical guidelines for implanted devices.

  • What regulatory pathway was followed for FDA clearance of this device, and what classification does it hold?

    The Cardiac Pacer Model 208 received FDA clearance under the traditional review pathway via a 510(k) submission (K780066). As a Class III device, it falls under strict regulatory oversight due to its life-sustaining nature, regulated under FDA regulation number 870.3610 for pacemaker pulse-generators.

  • How is this device supplied, and what considerations should be made for storage before implantation?

    The Cardiac Pacer Model 208 is supplied sterile and packaged for single-use implantation. Storage should adhere to manufacturer guidelines to maintain sterility, typically in a clean, dry environment away from direct sunlight or extreme temperatures until ready for surgical use.