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

No FDA recalls found in the data synced 11 Oct 2026.

510(k) Number

K001180 ↗

FDA Product Code

DTE

Models / Variants

5235

5235A

5235V

Temporary Pacemaker Surgical Extension Cable

Models 528

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

• 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

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