Model 325D Unipolar Cardiac Pulse Gen

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

510(k) Number

K822904 ↗

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 purpose of the Model 325D Unipolar Cardiac Pulse Generator and who should use it?

  The Model 325D Unipolar Cardiac Pulse Generator is designed to regulate cardiac rhythm by delivering electrical impulses to the heart, specifically for patients requiring unipolar pacing. It is intended for use in clinical settings where qualified medical professionals can implant it to maintain proper heart function in patients with pacing needs.

• Is the Model 325D Unipolar Cardiac Pulse Generator intended for single-use or reusable applications?

  The Model 325D is explicitly supplied sterile and intended for single-use implantation only. This ensures patient safety and compliance with strict sterility protocols required for implantable medical devices.

• How is this device regulated, and what does the FDA’s classification mean for its use?

  The Model 325D is classified as a Class III device under FDA regulations and has received 510(k) clearance (K822904). The clearance is marked as *substantially equivalent (SESE)*, meaning it is deemed comparable to a legally marketed predicate device in terms of safety and effectiveness. This classification ensures it meets rigorous standards for implantable cardiac devices.

• What special handling or storage requirements apply to the Model 325D before implantation?

  Since the Model 325D is supplied sterile and intended for single-use, it must be stored according to manufacturer guidelines to preserve sterility. This typically includes keeping it in its original packaging, away from extreme temperatures or contamination, until immediate use in a controlled clinical environment.