Model 340 Series Unipolar & Model 5000B Programmer

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

510(k) Number

K905403 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• 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. →

• What is the primary purpose of the Model 5000B Programmer in clinical settings?

  The Model 5000B Programmer is designed to configure and monitor the implanted Model 340 Series unipolar pacemakers. It allows clinicians to adjust pacing parameters and retrieve diagnostic data from the implanted pulse-generator, ensuring proper cardiac rhythm regulation for patients.

• Is the Model 5000B Programmer intended for single-use or can it be reused in multiple procedures?

  The Model 5000B Programmer is explicitly supplied as a reusable device, meaning it is engineered for repeated use in clinical settings with compatible Model 340 Series unipolar pacemakers.

• What regulatory pathway was followed for FDA clearance of the Model 340 Series Unipolar and Model 5000B Programmer?

  The Model 340 Series Unipolar pacemakers and Model 5000B Programmer were cleared through the FDA’s 510(k) pathway with a traditional review, determined to be *substantially equivalent* to a predicate device. The clearance (K905403) was issued under the Cardiovascular advisory committee and adheres to regulation 870.3610.

• Are the Model 340 Series pacemakers and Model 5000B Programmer compatible with each other?

  Yes, the Model 5000B Programmer is specifically authorized for use with the Model 340 Series unipolar pacemakers. It enables programming and diagnostic functions tailored to these implanted pulse-generators, ensuring seamless integration for cardiac rhythm management.