Astra T2, T3, T4 & T6 Multiprogram Pulse Generator

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

510(k) Number

K860585 ↗

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 types of arrhythmias can the Astra T2, T3, T4 & T6 Multiprogram Pulse Generator address, and how does it achieve this?

  The Astra T2, T3, T4 & T6 Multiprogram Pulse Generator is designed to regulate cardiac rhythm by delivering electrical impulses to address various arrhythmias. It supports multiple pacing programs, including atrial and ventricular pacing modes, which help ensure synchronized cardiac contractions. This flexibility allows it to manage a range of heart rhythm disorders by adjusting pacing sequences to match the patient’s specific needs.

• Is the Astra T2, T3, T4 & T6 Pulse Generator intended for reuse, or is it meant to be implanted as a single-use device?

  The Astra T2, T3, T4 & T6 Pulse Generator is supplied sterile and explicitly intended for single-use implantation. It is not designed for reuse, and proper surgical placement by a healthcare professional is required to ensure safe and effective use.

• How is the Astra T2, T3, T4 & T6 Pulse Generator regulated in the U.S., and what does this mean for clinicians?

  The Astra T2, T3, T4 & T6 Pulse Generator is classified as a Class III medical device under FDA regulations and has received FDA 510(k) clearance (K860585). This means it has undergone rigorous review by the FDA’s Cardiovascular (CV) advisory committee to ensure safety and effectiveness. Clinicians can rely on this regulatory pathway as confirmation that the device meets established performance standards for implantable pacemaker pulse-generators.

• What should clinicians consider when storing the Astra T2, T3, T4 & T6 Pulse Generator before implantation?

  Since the Astra T2, T3, T4 & T6 Pulse Generator is supplied sterile, it must be stored in its original packaging until ready for use to maintain sterility. Clinicians should follow the manufacturer’s guidelines for storage conditions, such as protecting it from moisture, extreme temperatures, and physical damage, to ensure the device remains functional and safe for implantation.