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Pulse Generator, Bipolar 3608

by Cardiac Pacemakers, Inc.

510(k) K770881

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 NumberK770881 Date20 Jun 1977ClearedStatusActive

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  • Withdrawn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
Generator, Pulse, Bipolar 3608
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.

This device is an Implantable Pacemaker Pulse-Generator, classified under FDA regulation 870.3610. It delivers electrical impulses to regulate heart rhythm in patients with bradycardia or other cardiac conduction disorders, ensuring consistent cardiac pacing through bipolar electrode stimulation.

The Pulse Generator, Bipolar 3608 is intended for surgical implantation and is classified as a Class III medical device under FDA guidelines. It was granted FDA 510(k) clearance (K770881) in 1977 as substantially equivalent to predicate devices, with no explicit mention of sterility, reusability, or MRI safety in the available data. Supplied as a single-use implantable component, it requires sterile handling and proper surgical implantation by qualified personnel.

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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 clinical purpose of the GENERATOR, PULSE, BIPOLAR 3608, and how does it function within the body?

    The GENERATOR, PULSE, BIPOLAR 3608 is an implantable pacemaker designed to regulate heart rhythm in patients with bradycardia or cardiac conduction disorders. It delivers electrical impulses through bipolar electrode stimulation to maintain consistent cardiac pacing, ensuring the heart beats at a proper rate.

  • Is this device intended for single-use or can it be reused after implantation?

    The GENERATOR, PULSE, BIPOLAR 3608 is explicitly described as a single-use implantable component. It is intended for surgical implantation by qualified personnel and requires sterile handling, meaning it is not designed for reuse.

  • What type of regulatory clearance does this device hold, and when was it granted?

    This device holds FDA 510(k) clearance (K770881) and was granted as substantially equivalent to predicate devices in 1977. The clearance was issued under the traditional review pathway, with the decision made on June 20, 1977.

  • How should the GENERATOR, PULSE, BIPOLAR 3608 be handled during and after surgical implantation?

    Due to its classification as a single-use implantable device, the GENERATOR, PULSE, BIPOLAR 3608 must be handled under sterile conditions during surgery. It is intended for permanent implantation by qualified medical personnel, so post-implantation handling involves standard medical device management protocols for implanted devices.

  • What is the manufacturer’s address for the GENERATOR, PULSE, BIPOLAR 3608?

    The manufacturer, Cardiac Pacemakers, Inc., is located at 4221 Richmond Rd., NW, Walker, MI 49534, USA. This address is provided in the regulatory filing data.