Models 4201, 4231 & 4235 Extension Cables - 4231

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K902679 ↗

FDA Product Code

DTE

Models / Variants

4201

4231

4235 Extension Cables

Device Class

Class II

Regulation

21 CFR Part 870.3600

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Model 4205 Pulse Generator Surgical Exten Cable

  Class III

  FDA 510(k) K912545 Active Cleared 26 Jul 1991

• Model 4815 Adapter

  Class II

  FDA 510(k) K002496 Active Cleared 10 Oct 2000

• Temporary Pacemaker Extension Cable, Models 5235, 5235A, 5235V, Temporary Pacemaker Surgical Extension Cable, Models 528

  Class II

  FDA 510(k) K001180 Active Cleared 27 Jun 2000

• Model 4800 Accupace Pacing System Analyer

  Class II

  FDA 510(k) K925143 Active Cleared 27 Sep 1994

• Model 3110 Heart Wire & 3110P Pediatric Heart Wire

  Class II

  FDA 510(k) K890988 Active Cleared 25 Aug 1989

• Pace Implant. Lead/Tined/Atrial/J/Model 3290

  Class III

  FDA 510(k) K864153 Active Cleared 6 Jan 1987

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• What are the Pace Medical 4201, 4231 & 4235 Extension Cables used for?

  These extension cables connect implanted pacemaker systems to external monitoring or programming devices. They ensure reliable signal transmission between the pacemaker generator and diagnostic or programming equipment, enabling proper pacing functionality and patient monitoring in clinical settings like hospitals or cardiac care units.

• Are these extension cables single-use or reusable?

  The Pace Medical 4201, 4231 & 4235 Extension Cables are designed as reusable medical devices. They are intended for repeated use in clinical environments, adhering to standards for cardiovascular device durability and reliability.

• What types of connectors do these extension cables include?

  Each model (4201, 4231, and 4235) features specific connectors tailored for compatibility with different pacemaker systems. These connectors ensure proper interfacing between the extension cable and the implanted pulse generator or external monitoring/programming equipment.

• How are these extension cables classified under FDA regulations?

  These cables are classified as Class II devices under FDA regulations, with a product code of DTE (Diagnostic Electrical). They were granted a Substantially Equivalent (SE) 510(k) clearance in 1990, confirming their compliance with cardiovascular device standards.

• Where are these extension cables intended for use?

  The Pace Medical 4201, 4231 & 4235 Extension Cables are supplied for clinical settings such as hospitals and cardiac care units. Their design supports reliable signal transmission in environments where external monitoring or programming of pacemaker systems is required.