Cook Pacemaker 33IT R Unipolar Cardiac Pulse Gener

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

510(k) Number

K853651 ↗

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 33IT R Unipolar Cardiac Pulse Generator, and how does it function in patients?

  The Cook Pacemaker 33IT R Unipolar Cardiac Pulse Generator is designed to deliver electrical stimulation to the heart, helping regulate cardiac rhythm in patients with bradycardia (slow heart rate) or conduction disorders. It contains a power supply and electronic circuitry to generate periodic pulses that maintain a consistent heartbeat when the heart’s natural rhythm is impaired.

• Is this device intended for single-use or can it be reused after implantation?

  The available data does not specify whether the Cook Pacemaker 33IT R Unipolar Cardiac Pulse Generator is intended for single-use or reuse. Since it is an implantable device, it is typically designed for long-term use within the patient’s body, but reuse would not be standard practice for implanted medical devices.

• How is the Cook Pacemaker 33IT R Unipolar Cardiac Pulse Generator supplied, and are there any sterility requirements mentioned?

  The regulatory data does not explicitly state sterility requirements for the Cook Pacemaker 33IT R Unipolar Cardiac Pulse Generator. However, as an implantable device, it would typically be supplied in a sterile packaging to prevent infection during implantation. For precise handling instructions, refer to the manufacturer’s packaging or accompanying documentation.

• What regulatory pathway was used for the FDA clearance of this device, and when was it cleared?

  The Cook Pacemaker 33IT R Unipolar Cardiac Pulse Generator was cleared via a traditional 510(k) submission (K853651) under the FDA’s Premarket Notification Program. It was determined to be substantially equivalent to a legally marketed predicate device and received clearance on October 23, 1985.

• Does this device come in multiple sizes or models, and how would one determine the appropriate model for a patient?

  The available data does not specify different sizes or models for the Cook Pacemaker 33IT R Unipolar Cardiac Pulse Generator. Selection of the appropriate device would typically be based on clinical assessment, patient anatomy, and the specific requirements of the patient’s cardiac condition. Consultation with the manufacturer or a cardiologist is recommended for proper device selection.