Cook Pacemaker 332T Series R Bipolar Cardiac Pulse-Generator

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

Full name

Cook Pacemaker 332T, Series R Bipolar Cardiac Puls

510(k) Number

K854132 ↗

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 Cook Pacemaker 332T Series R Bipolar Cardiac Pulse-Generator, and how does it function in the body?

  The Cook Pacemaker 332T Series R Bipolar Cardiac Pulse-Generator is designed to regulate cardiac rhythm by delivering controlled electrical impulses to the heart. It acts as an implantable device that compensates for abnormal heartbeats, ensuring proper pacing when the heart’s natural electrical system fails to maintain an effective rhythm.

• Is this device intended for single-use or can it be reused after implantation, and what does that mean for clinical workflow?

  The Cook Pacemaker 332T Series R is classified as a pulse-generator that follows standard pacemaker practices, meaning it is typically intended for single-use implantation—though the pulse-generator itself may be reusable in a clinical setting if properly maintained and sterilized (if applicable). Clinically, this means the device is implanted once per patient, but the manufacturer’s design allows for potential reuse of the pulse-generator component in other procedures under controlled conditions.

• What regulatory pathway was followed for FDA clearance of this device, and when was it approved?

  The Cook Pacemaker 332T received FDA clearance under a Traditional 510(k) pathway with a *Substantially Equivalent (SESE)* determination, meaning it was deemed comparable to a legally marketed predicate device. The clearance was granted on December 3, 1985, under the product code DXY for Implantable Pacemaker Pulse-Generators, regulated under 21 CFR 870.3610.

• Are there any specific storage requirements mentioned for this device, and how should it be handled before implantation?

  The provided data does not specify sterility or storage conditions for the Cook Pacemaker 332T Series R. However, as a Class III implantable device, standard medical device storage practices—such as protecting it from moisture, extreme temperatures, and contamination—should be followed. Clinicians should refer to the manufacturer’s instructions for packaging and handling to ensure proper sterility and functionality before implantation.