Kelvin Model 513 Unipolar and Model 514 Bipolar Cardiac Pulse Generators

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

Full name

Kelvin(R) Model 513 Unipolar and Model 514 Bipolar Cardiac Pulse Generators.

Trade Name

Kelvin Model 500 Unipolar Cardiac Pulse Generator

Generic Name

implantable pacemaker Pulse-generator

PMA Number

P870054 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

APWD Approval withdrawn

• Needle's Eye Snare

  Class II

  FDA 510(k) K961992 Active Cleared 27 Dec 1996

• Model P In-Line Bipolar Endocardial Tined Lead

  Class III

  FDA 510(k) K915188 Active Cleared 11 Sep 1992

• Cook Pacemaker Corp. 327T Series R Unipolar Cardi

  Class III

  FDA 510(k) K853590 Active Cleared 23 Oct 1985

• Model F Unipolar Endocardial Lead

  Class III

  FDA 510(k) K832255 Active Cleared 12 Aug 1983

• Model 325D Unipolar Cardiac Pulse Gen

  Class III

  FDA 510(k) K822904 Active Cleared 15 Oct 1982

• Model 329T Programmable, Bipolar Cardi

  Class III

  FDA 510(k) K832893 Active Cleared 4 Oct 1983

See all devices from Cook Pacemaker Corp. →