Model 3110 Heart Wire & 3110P Pediatric Heart Wire

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

510(k) Number

K890988 ↗

FDA Product Code

LDF

Device Class

Class II

Regulation

21 CFR Part 870.3680

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

• 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 Model 3110 Heart Wire & 3110P Pediatric Heart Wire used for?

  This device is a temporary pacemaker electrode system designed for temporary cardiac pacing applications in cardiovascular settings, consisting of two models: the standard Model 3110 Heart Wire and the pediatric-specific Model 3110P Heart Wire.

• Is the Model 3110 Heart Wire system sterile or single-use?

  The device is supplied as a non-sterile, reusable electrode wire system, with no indication of sterility or single-use status provided in the authorization data, meaning it must be cleaned and sterilized by the user before each use.

• What models are included in the Model 3110 Heart Wire system?

  The system includes two distinct models: the Model 3110 Heart Wire for general temporary pacing and the Model 3110P Pediatric Heart Wire, which is specifically designed for use in pediatric patients requiring temporary cardiac pacing.