Model 327D, Series R Unipolar Cardiac Pulse Gener.

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

510(k) Number

K860202 ↗

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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See all devices from Cook Pacemaker Corp. →

• What is the primary clinical purpose of the Model 327D Series R Unipolar Cardiac Pulse Generator, and who should use it?

  The Model 327D is designed to regulate heart rhythm in patients with bradycardia or cardiac conduction disorders by delivering electrical impulses. It is intended for single-use implantation by qualified healthcare professionals in controlled clinical settings, such as electrophysiologists or cardiologists, during cardiovascular procedures.

• Is this device reusable, or is it meant for one-time use after implantation?

  The Model 327D is explicitly intended for single-use implantation. Once implanted, it is not designed for removal or reuse, aligning with standard practices for implantable pacemaker pulse generators to ensure patient safety and sterility.

• How is the Model 327D supplied, and what precautions should be taken during handling?

  The device is supplied sterile, requiring adherence to strict sterile techniques during implantation. Since it is intended for single-use in a controlled clinical setting, it must be handled in an environment that maintains aseptic conditions to prevent contamination before and during the procedure.

• What regulatory pathway was followed for FDA clearance of this device, and what does that mean for clinicians?

  The Model 327D received FDA clearance through a traditional 510(k) review pathway, determined to be substantially equivalent to a legally marketed predicate device. This means it meets FDA standards for safety and effectiveness as an implantable pacemaker pulse generator, but clinicians should confirm compatibility with their specific patient needs and institutional protocols.

• Are there any special considerations for storage or compatibility with other medical equipment, such as MRI machines?

  The Model 327D is not MRI-safe, meaning it should not be used in patients who require MRI scans. While storage specifications are not detailed in the regulatory data, standard practices for implantable devices—such as protecting from physical damage and extreme temperatures—should be followed to maintain functionality until implantation.