Model 4205 Pulse Generator Surgical Exten Cable

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

510(k) Number

K912545 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• 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

• Pacing Leads Model 3262VU/Vb, 3362VU/Vb, 3380/3390

  Class III

  FDA 510(k) K874743 Active Cleared 19 Jan 1988

See all devices from Pace Medical →

• What is the primary purpose of the Model 4205 Pulse Generator Surgical Extension Cable in a pacemaker system?

  The Model 4205 Surgical Extension Cable is designed to serve as a reusable extension between the pulse generator and other components of the pacemaker circuit. Its role is to ensure reliable transmission of electrical signals during cardiovascular surgical procedures, maintaining proper pacing functionality.

• Is this device intended for single-use or can it be reused in multiple procedures?

  This device is explicitly labeled as a reusable component, intended for use in cardiovascular surgical settings. It is not classified as single-use, though proper sterilization and maintenance procedures should be followed to ensure safety and functionality across multiple uses.

• What regulatory pathway was followed for FDA clearance of this device, and when was it determined as substantially equivalent?

  The Model 4205 Pulse Generator Surgical Extension Cable received FDA clearance through a 510(k) submission (K912545) under the Traditional review pathway. It was granted a Substantially Equivalent (SESE) determination by the Cardiovascular (CV) Advisory Committee on July 26, 1991, following review of its submission filed on June 10, 1991.

• Does this device have any specific sterility or MRI safety requirements mentioned in the available data?

  The available data does not explicitly mention sterility specifications or MRI safety requirements for the Model 4205 Surgical Extension Cable. Since it is reusable, proper cleaning and sterilization protocols would be necessary for clinical use, though these details are not detailed in the regulatory submission.

• What types of surgical settings is this device intended for, and what medical specialty does it fall under?

  This device is specifically designed for cardiovascular surgical settings, where pacemaker systems are implanted or adjusted. It falls under the Cardiovascular medical specialty, as indicated in the regulatory data, and is categorized under Product Code DXY (Implantable Pacemaker Pulse-Generator).