Software Module/2035 Prog and Astra/T Pulse Gen

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

510(k) Number

K860584 ↗

FDA Product Code

KRG

Device Class

Class III

Regulation

21 CFR Part 870.3700

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 is the primary purpose of the SOFTWARE MODULE/2035 PROG AND ASTRA/T PULSE GEN, and how does it differ from manual pacemaker adjustments?

  This device is a Pacemaker Programmer designed to noninvasively adjust electrical operating characteristics of implantable pacemakers. Unlike manual adjustments, it allows clinicians to remotely modify pacing parameters such as rate, output, and timing through programming and pulse generation—eliminating the need for invasive procedures. It’s specifically tailored for use in clinical settings by trained healthcare professionals.

• Is this device intended for single-use or reusable applications, and what guidance should clinicians follow?

  The SOFTWARE MODULE/2035 PROG AND ASTRA/T PULSE GEN is supplied as a standalone programmer with flexibility for either single-use or reusable applications, depending on the manufacturer’s established guidelines. While the data does not specify sterility or MRI safety details, clinicians should adhere strictly to the manufacturer’s instructions for proper use, cleaning, and maintenance to ensure safety and efficacy.

• What regulatory pathway was followed for this device’s approval, and which advisory committee was involved?

  This device was cleared through the FDA’s 510(k) pathway under Traditional review, with a decision date of June 6, 1986. It falls under the Cardiovascular (CV) advisory committee and is classified as a Class III device, though the 510(k) clearance (K860584) indicates it was deemed substantially equivalent to a predicate device at the time of submission.

• What types of pacemaker systems is this programmer compatible with, and how does it support clinical workflows?

  The SOFTWARE MODULE/2035 PROG AND ASTRA/T PULSE GEN is designed for use with implantable pacemaker systems, enabling clinicians to program and generate pulses for devices like the Astra/T series. It supports workflows by providing precise, noninvasive adjustments to pacing parameters—such as rate, output, and timing—directly from the programmer, streamlining patient management in clinical settings.

• How should this device be stored, and are there any specific handling instructions provided in the data?

  The provided data does not include explicit storage instructions or handling details for the SOFTWARE MODULE/2035 PROG AND ASTRA/T PULSE GEN. Clinicians should refer to the manufacturer’s official documentation for proper storage conditions, environmental requirements, and any maintenance protocols to ensure optimal performance and longevity of the device.