Model 5600B Pacemaker Programmer

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

Full name

Model 5600B Programmer, Pacemaker

510(k) Number

K871986 ↗

FDA Product Code

KRG

Device Class

Class III

Regulation

21 CFR Part 870.3700

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Slimline Unipolar Endocardial Pacing Lead, 030-438

  Class III

  FDA 510(k) K865098 Active Cleared 18 Aug 1987

• Model 030-437 Implant Electrode

  Class III

  FDA 510(k) K870610 Active Cleared 20 Mar 1987

• Sterile Packaging

  Class III

  FDA 510(k) K810410 Active Cleared 5 Mar 1981

• Implantable Programmable Bipolar Cardiac (K800573)

  Class III

  FDA 510(k) K800573 Active Cleared 25 Mar 1980

• Laserpor Ap Atrial Endocard. Electr. Ld.

  Class III

  FDA 510(k) K820121 Active Cleared 12 Feb 1982

• Electrode, Model 030-324

  Class II

  FDA 510(k) K781822 Active Cleared 8 Feb 1979

See all devices from Telectronics, Inc. →

• What clinical settings is the Model 5600B Pacemaker Programmer intended for use in and who operates it?

  The Model 5600B Pacemaker Programmer is designed for use in clinical settings like cardiac electrophysiology labs or hospital wards. It is intended for trained healthcare professionals, such as cardiologists or electrophysiologists, who specialize in managing cardiac rhythm disorders.

• Is the Model 5600B Pacemaker Programmer a single-use or reusable device, and what maintenance does it require?

  The Model 5600B Pacemaker Programmer is a reusable medical instrument. Since it is classified as a reusable device, it requires proper calibration and regular maintenance to ensure accurate and reliable performance for adjusting pacing parameters in implanted pacemakers.

• What types of pacing parameters can the Model 5600B Pacemaker Programmer adjust, and why is this important?

  The Model 5600B Pacemaker Programmer allows noninvasive adjustment of pacing parameters such as pacing rates, output levels, and timing intervals. These adjustments are critical for optimizing cardiac rhythm management in patients with bradycardia or other pacing-dependent conditions, ensuring their pacemakers function effectively.

• What regulatory pathway was followed for the FDA clearance of the Model 5600B Pacemaker Programmer, and when was it granted?

  The Model 5600B Pacemaker Programmer received FDA clearance through a 510(k) submission, specifically under the Traditional clearance type. It was granted Substantially Equivalent (SESE) status in 1987, adhering to regulatory standards for cardiovascular devices as reviewed by the Cardiovascular (CV) Advisory Committee.