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Durapulse Implantable Pacemaker Pulse-Generator

by Cpm International, Inc.

510(k) K823371

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 NumberK823371 Date22 Dec 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  • Withdrawn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
Durapulse
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 Durapulse Implantable Pacemaker Pulse-Generator is a Class III medical device classified under the FDA’s regulation number 870.3610. It functions as an implantable device designed to regulate cardiac rhythm by delivering electrical impulses to the heart when necessary, ensuring proper pacing and maintaining normal heart function in patients with bradycardia or other pacing-dependent conditions.

This device is intended for surgical implantation and is supplied sterile for single-use. It is regulated under the FDA’s 510(k) clearance process, with a decision code of SESE (Substantially Equivalent) following review by the Cardiovascular (CV) Advisory Committee. The device is manufactured by CPM International, Inc., and is identified by the product code DXY. Compliance with MRI safety standards and specific storage conditions are not detailed in the provided data.

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 Durapulse Implantable Pacemaker Pulse-Generator and who would benefit from it?

    The Durapulse Implantable Pacemaker Pulse-Generator is designed to regulate cardiac rhythm by delivering electrical impulses to the heart when needed. It is intended for patients with bradycardia or other pacing-dependent conditions, ensuring proper pacing and maintaining normal heart function. This device is specifically for surgical implantation and is used in patients requiring chronic cardiac stimulation.

  • Is the Durapulse device meant for single-use or can it be reused after implantation?

    The Durapulse Implantable Pacemaker Pulse-Generator is supplied sterile and intended for single-use. Once implanted, it is not designed for removal or reuse, as it is a permanent device meant to remain in place for long-term cardiac rhythm management.

  • How was the Durapulse device regulated by the FDA, and what does the decision code SESE indicate?

    The Durapulse device was regulated under the FDA’s 510(k) clearance process and was reviewed by the Cardiovascular (CV) Advisory Committee. The decision code SESE (Substantially Equivalent) indicates that the FDA determined it is substantially equivalent to a legally marketed device in terms of technology and safety, meaning it meets the same performance standards as its predecessor.

  • What storage conditions should be followed for the Durapulse device before implantation?

    While specific storage conditions are not detailed in the provided data, the device is supplied sterile and must be handled according to standard sterile medical device protocols. It should be stored in a clean, dry environment, protected from contamination, and used within its expiration date to ensure safety and efficacy.