#325 Programmable Card. Pulse Generator

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

510(k) Number

K810884 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Needle's Eye Snare

  Class II

  FDA 510(k) K961992 Active Cleared 27 Dec 1996

• Model P In-Line Bipolar Endocardial Tined Lead

  Class III

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• Cook Pacemaker Corp. 327T Series R Unipolar Cardi

  Class III

  FDA 510(k) K853590 Active Cleared 23 Oct 1985

• Model F Unipolar Endocardial Lead

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• Model 325D Unipolar Cardiac Pulse Gen

  Class III

  FDA 510(k) K822904 Active Cleared 15 Oct 1982

• Model 329T Programmable, Bipolar Cardi

  Class III

  FDA 510(k) K832893 Active Cleared 4 Oct 1983

See all devices from Cook Pacemaker Corp. →

• What is the primary clinical purpose of the #325 Programmable Cardiac Pulse Generator, and who is it designed for?

  The #325 Programmable Cardiac Pulse Generator is designed to regulate cardiac rhythm by delivering timed electrical impulses to the heart. It is intended for patients with bradycardia (slow heart rate) or other conduction disorders that require artificial pacing to maintain proper heart function. This device is specifically classified as an Implantable Pacemaker Pulse-Generator and is used in cardiovascular applications.

• Is this device intended for single-use or can it be reused after implantation?

  The #325 Programmable Cardiac Pulse Generator is explicitly described as a reusable device. Since it is implanted within the patient, it is not discarded after a single use but remains in place for long-term cardiac rhythm management. Reusability is consistent with the design of implantable pacemakers, which are intended to function continuously over many years.

• What regulatory pathway was followed for FDA clearance of this device, and how does that affect its use?

  The #325 Programmable Cardiac Pulse Generator received FDA clearance through a 510(k) premarket notification process with a traditional review, meaning its safety and effectiveness were evaluated by the FDA against existing pacemaker standards. It was determined to be substantially equivalent to a legally marketed predicate device, ensuring compliance with strict manufacturing and performance requirements for Class III, life-sustaining medical devices. This clearance allows for its use in clinical settings under FDA oversight.

• How is this device supplied, and are there any specific storage requirements mentioned?

  The device is supplied as an implantable, reusable unit—it is not a disposable or single-use item. While the provided data does not specify detailed storage conditions (such as temperature or humidity), typical implantable pacemakers require sterile packaging and handling before implantation. After implantation, the device remains within the patient’s body and does not require external storage. Always follow manufacturer guidelines for pre-implantation preparation and handling.