Model 325C Unipolar Cardiac Pulse Gen.

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

510(k) Number

K812832 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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• Cook Pacemaker Corp. 327T Series R Unipolar Cardi

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• Model 325D Unipolar Cardiac Pulse Gen

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  FDA 510(k) K832893 Active Cleared 4 Oct 1983

See all devices from Cook Pacemaker Corp. →

• What is the primary purpose of the Model 325C Unipolar Cardiac Pulse Generator, and what types of patients would benefit from it?

  The Model 325C Unipolar Cardiac Pulse Generator is designed to deliver electrical impulses to regulate heart rhythm in patients with bradycardia or other cardiac conduction disorders. It is intended for use in unipolar pacing configurations, providing consistent and reliable cardiac stimulation to maintain proper heart function in individuals whose natural pacemaker signals are insufficient or disrupted.

• Is the Model 325C Unipolar Cardiac Pulse Generator intended for single-use or reusable applications, and how should it be handled?

  The Model 325C is explicitly intended for single-use implantation within the human body. Since it is supplied sterile, proper sterile medical device protocols must be followed during storage and handling to preserve its integrity and ensure patient safety. Reuse is not recommended or supported by the manufacturer.

• What regulatory pathway does the Model 325C follow, and how does this affect its use in clinical settings?

  The Model 325C Unipolar Cardiac Pulse Generator is regulated under the FDA 510(k) clearance process (K812832) and is classified as a Class III device, which is the highest risk category for medical devices. This classification ensures rigorous review by the FDA’s Cardiovascular (CV) advisory committee before clearance. Clinically, this means it has undergone thorough evaluation for safety and effectiveness in treating bradycardia or conduction disorders, adhering to strict manufacturing and performance standards.

• How should the Model 325C be stored to maintain its sterility and functionality before implantation?

  The Model 325C is supplied sterile, so storage must comply with sterile medical device protocols to prevent contamination. This includes keeping it in its original packaging, away from direct sunlight or extreme temperatures, and following the manufacturer’s guidelines for shelf life and handling. Proper storage ensures the device remains safe and effective for its intended single-use implantation.