Model 329T Programmable, Bipolar Cardi

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

510(k) Number

K832893 ↗

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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See all devices from Cook Pacemaker Corp. →

• What is the primary clinical purpose of the Model 329T Programmable, Bipolar Cardi pacemaker, and who is it designed for?

  The Model 329T is designed to regulate heart rhythm by delivering electrical impulses to the heart muscle, specifically for patients with bradycardia or other cardiac conduction disorders requiring consistent pacing support. It is intended for surgical implantation and provides programmable pacing to ensure precise and reliable heart function.

• Is the Model 329T meant for reuse, or is it a single-use device, and how is it supplied?

  The Model 329T is supplied sterile and intended for single-use only. It is not designed for reuse, which aligns with its classification as an implantable device requiring sterile conditions during and after surgical implantation.

• What type of regulatory clearance does the Model 329T hold, and what does this mean for its use?

  The Model 329T holds FDA 510(k) clearance (K832893) under the traditional review pathway, meaning it has been determined to be substantially equivalent to a legally marketed device. This clearance confirms its compliance with FDA regulations for use as an implantable pacemaker pulse-generator, ensuring safety and effectiveness for its intended clinical purpose.

• Does the Model 329T have any specific configuration that affects how it interacts with the heart?

  Yes, the Model 329T operates in a bipolar configuration, which means it delivers pacing impulses through two electrodes. This design minimizes tissue stimulation while ensuring precise pacing, reducing potential discomfort or complications for the patient.

• What storage or handling considerations should be taken into account for the Model 329T before implantation?

  Since the Model 329T is supplied sterile and intended for single-use, it must be stored in its original packaging until ready for use to maintain sterility. Proper handling and adherence to sterile procedures are critical to prevent contamination before surgical implantation.