Astra T2, T4, and T6 Implantable Pacemaker Pulse-Generator

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

Full name

Astra T2, T4 and T6

510(k) Number

K865013 ↗

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. →

• Are the Astra T2, T4, and T6 pacemakers intended for reuse with multiple patients, or are they single-use devices?

  The Astra T2, T4, and T6 pacemaker pulse-generators are explicitly designed for single-patient use only. Since they are implanted subcutaneously in the chest, they are not intended to be shared or reused across patients, adhering to standard practices for implantable medical devices.

• What are the key differences between the Astra T2, T4, and T6 models, and how might a clinician choose between them?

  The provided data does not specify technical or functional differences between the Astra T2, T4, and T6 models beyond their classification as implantable pacemaker pulse-generators. Selection would typically depend on clinical factors such as pacing requirements, patient anatomy, or compatibility with other components (e.g., leads). For precise guidance, consult the manufacturer’s clinical documentation or technical specifications, as these models may vary in programming capabilities, battery life, or other performance metrics not detailed here.

• How are the Astra T2, T4, and T6 pacemakers regulated by the FDA, and what does the product code DXY indicate?

  The Astra T2, T4, and T6 pacemakers are regulated under FDA 510(k) clearance (K865013) and classified as Class III devices, requiring premarket approval due to their role in life-sustaining functions. The product code DXY categorizes them under the FDA’s cardiovascular device classification, specifically for implantable pacemaker pulse-generators, aligning with their intended use for regulating heart rhythm via electrical impulses.

• Do the Astra T2, T4, and T6 pacemakers come with any specific storage or handling instructions, particularly regarding sterility?

  The data does not provide explicit sterility specifications or storage instructions for the Astra T2, T4, and T6 pacemakers. However, as implantable devices, they are typically packaged in sterile, single-use packaging to prevent contamination before implantation. For proper handling, storage, and expiration details, refer to the manufacturer’s instructions for use (IFU) or packaging labels, as these are critical for maintaining device integrity and patient safety.

• What is the historical context of the FDA’s review process for these pacemakers, and how was their substantial equivalence determined?

  The Astra T2, T4, and T6 pacemakers were submitted to the FDA under a Traditional 510(k) pathway and received clearance on February 19, 1987, with a decision code of SESE (Substantially Equivalent in Safety and Effectiveness). This determination was made by the Cardiovascular (CV) Advisory Committee, comparing them to a predicate device already on the market. The review process confirmed they met the FDA’s requirements for cardiovascular implantable pulse generators, ensuring they performed similarly to existing approved devices while maintaining safety standards.