Skip to content

Astra T2, T3, T4, T6 Pulse Generators

by Cardiac Pacemakers, Inc.

510(k) K890785

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 NumberK890785 Date10 Mar 1989ClearedStatusActive

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  • Withdrawn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
Astra T2, T3, T4, T6 Pulse Generators New Package
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, 20 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 Astra T2, T3, T4, and T6 Pulse Generators are implantable pacemaker pulse-generators, designed to regulate heart rhythm by delivering electrical impulses to the heart muscle. These devices are classified under FDA regulation 870.3610 and fall within the cardiovascular specialty, providing pacing therapy for patients with bradycardia or other cardiac conduction disorders.

These pulse generators are intended for surgical implantation and are supplied as a sterile, single-use device in a new package. They are regulated under FDA 510(k) clearance (K890785) and classified as Class III medical devices. The devices are manufactured by Cardiac Pacemakers, Inc. (now part of Boston Scientific) and are approved for use in clinical settings requiring cardiac rhythm management solutions.

Other devices from Cardiac Pacemakers, Inc.

See all devices from Cardiac Pacemakers, Inc. →

Questions

AI-generated answers, 20 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • Are the Astra T2, T3, T4, and T6 Pulse Generators designed for reuse or single-use, and how is sterility maintained?

    The Astra T2, T3, T4, and T6 Pulse Generators are supplied as sterile, single-use devices in a new package. This ensures sterility is maintained for one-time surgical use, reducing the risk of contamination during implantation.

  • What types of cardiac conditions are these pulse generators intended to address?

    These pulse generators are intended to regulate heart rhythm by delivering electrical impulses to the heart muscle, specifically for patients with bradycardia or other cardiac conduction disorders requiring pacing therapy.

  • How are these devices regulated, and what does the FDA clearance indicate about their safety and effectiveness?

    The Astra T2, T3, T4, and T6 Pulse Generators are classified as Class III medical devices and have received FDA 510(k) clearance under the reference number K890785. This clearance indicates that the manufacturer has demonstrated the device is substantially equivalent to a legally marketed predicate device in terms of safety and effectiveness, as determined by the FDA.

  • What is the manufacturer’s address and contact information for inquiries about these pulse generators?

    The manufacturer, Cardiac Pacemakers, Inc. (now part of Boston Scientific), is located at 4100 Hamline Ave., N., P.O. Box 64079, St. Paul, MN 55112. For inquiries, you may contact Helen Bucko, though direct contact details are not provided in the regulatory data.