Astra T2, Astra T4, Astra T6

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K920601 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Acuity Universal Cutter

  Class II

  FDA 510(k) K080154 Active Cleared 20 Mar 2008

• Pacemaker Programmer #2010

  Class III

  FDA 510(k) K811217 Active Cleared 20 Jul 1981

• Microthin-Pii Bipolar Pulse Gen. #0623

  Class III

  FDA 510(k) K803034 Active Cleared 22 Dec 1980

• Astra 2, 3, 4 and 6: Chip Revision

  Not classified

  FDA 510(k) K863000 Active Cleared 19 Aug 1986

• Command Ultra I Implantable Pacemaker Pulse-Generator

  Class III

  FDA 510(k) K831161 Active Cleared 15 Jun 1983

• Elgiloy Stylet

  Class II

  FDA 510(k) K770243 Active Cleared 14 Feb 1977

See all devices from Cardiac Pacemakers, Inc. →

• What are the Astra T2, T4, and T6 pacemakers primarily used for in clinical practice?

  The Astra T2, T4, and T6 are designed to regulate cardiac rhythm in patients with bradycardia or conduction system disorders. They deliver electrical impulses to stimulate the heart when the body’s natural conduction system fails, ensuring consistent and reliable cardiac output. These devices are intended for surgical implantation by qualified healthcare professionals to address chronic slow heart rhythms or blockages.

• Are the Astra T2, T4, and T6 pacemakers intended for single-use or can they be reused?

  These devices are supplied sterile for single-use only. The manufacturer specifies that they are not designed for reuse, ensuring patient safety and compliance with medical device standards for implantable cardiac devices.

• How are the Astra T2, T4, and T6 pacemakers classified under FDA regulations, and what does this mean for their use?

  The Astra T2, T4, and T6 are classified as FDA Device Class 3 under regulation number 870.3610, which applies to implantable pacemaker pulse generators. This classification indicates they undergo rigorous review to ensure safety and effectiveness, and their use requires surgical implantation by qualified professionals in controlled clinical settings with appropriate monitoring.

• What is the regulatory pathway taken by the Astra T2, T4, and T6 pacemakers, and how does this affect their availability?

  The Astra T2, T4, and T6 pacemakers received FDA clearance through a 510(k) submission, specifically under the traditional review pathway with a decision described as ‘Substantially Equivalent.’ This means the manufacturer demonstrated that their device is as safe and effective as a legally marketed predicate device, allowing them to enter the market for clinical use in the U.S. after clearance.

• Do the Astra T2, T4, and T6 pacemakers come in different models, and if so, what should clinicians consider when selecting one?

  Yes, the Astra series includes three models—T2, T4, and T6—which may vary in specifications such as battery capacity and programming features. Clinicians should consider patient-specific needs, such as pacing requirements and expected longevity, when selecting a model. While the exact differences between models aren’t detailed here, the manufacturer’s documentation would outline these variations to guide clinical decision-making.