Model 327T Unipolar Cardiac Pulse Gen

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

510(k) Number

K832052 ↗

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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• Model P In-Line Bipolar Endocardial Tined Lead

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• Cook Pacemaker Corp. 327T Series R Unipolar Cardi

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• Model F Unipolar Endocardial Lead

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• Model 325D Unipolar Cardiac Pulse Gen

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• Model 329T Programmable, Bipolar Cardi

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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 327T Unipolar Cardiac Pulse Generator and how does it function in the body?

  The Model 327T Unipolar Cardiac Pulse Generator is designed to serve as an implantable pacemaker, providing periodic electrical pulses to stimulate the heart when its natural rhythm is disrupted. It operates in unipolar mode, delivering pacing impulses to correct intermittent or continuous cardiac rhythm disorders by acting as a substitute for the heart’s intrinsic pacing system.

• Is the Model 327T intended for reuse or single-use after implantation, and how is it supplied?

  The Model 327T is intended for single-use after surgical implantation. It is supplied sterile, adhering to cardiovascular medical specialty standards, ensuring it meets the necessary clinical requirements before use.

• What regulatory pathway was followed for FDA clearance of this device, and what classification does it hold?

  The Model 327T was cleared through the traditional 510(k) review pathway under FDA’s Class III device classification (product code DXY, regulation 870.3610). It was determined to be substantially equivalent to a predicate device, with clearance granted on August 8, 1983.

• How is this device categorized in terms of medical specialty, and what does that imply for its intended clinical use?

  The Model 327T falls under the cardiovascular medical specialty, meaning it is specifically designed for use in procedures and treatments related to heart function. This classification aligns with its role as an implantable pacemaker pulse-generator, ensuring it meets standards for cardiac rhythm management.