Programmer Model 2035/ELECTROGRAM Cable Model 6580

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

510(k) Number

K863045 ↗

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 clinical settings is this device intended for use in and by whom?

  The Programmer Model 2035/Electrogram Cable Model 6580 is designed for use in clinical settings like electrophysiology labs or cardiac catheterization suites. It is intended for trained healthcare professionals who specialize in cardiac rhythm management, such as electrophysiologists or cardiologists, to program, monitor, and diagnose implantable pacemakers and defibrillators.

• Is this device single-use or reusable, and what sterilization requirements apply?

  This device is a reusable medical instrument, meaning it is intended for repeated use after proper sterilization and maintenance. The manufacturer provides specific guidelines for sterilization and upkeep to ensure safety and functionality, which must be followed strictly in clinical environments.

• What regulatory pathway was followed for FDA clearance, and what does this classification mean for its use?

  The Programmer Model 2035/Electrogram Cable Model 6580 received FDA clearance through a 510(k) submission under the Traditional Review pathway, classified as Substantially Equivalent (SESE) to a predicate device. It falls under Device Class 3, adhering to strict cardiovascular medical device standards, which ensures rigorous safety and performance evaluations before clinical use.

• What types of implantable devices can this programmer interact with, and what functions does it support?

  This programmer is specifically designed to interact with implantable cardiac rhythm management systems, including pacemakers and defibrillators. It supports key functions like electrogram acquisition (recording electrical activity), pacing parameter adjustments (modifying device settings), and diagnostic data retrieval (analyzing stored information) to aid in clinical assessment and device optimization.

• How is this device categorized in terms of medical specialty and regulatory oversight?

  The device is categorized under the Cardiovascular medical specialty and falls under FDA regulation 870.3700, which governs pacemaker programmers. Its classification as Device Class 3 indicates it is subject to stringent pre-market approval processes to ensure safety and efficacy in managing cardiac rhythm disorders.