Model 325T Programmable Pulse Generator

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

510(k) Number

K812358 ↗

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

  FDA 510(k) K915188 Active Cleared 11 Sep 1992

• Cook Pacemaker Corp. 327T Series R Unipolar Cardi

  Class III

  FDA 510(k) K853590 Active Cleared 23 Oct 1985

• Model F Unipolar Endocardial Lead

  Class III

  FDA 510(k) K832255 Active Cleared 12 Aug 1983

• 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 purpose of the Model 325T Programmable Pulse Generator and how does it function in a clinical setting?

  The Model 325T Programmable Pulse Generator is designed to generate and deliver electrical impulses to regulate cardiac rhythm in patients who require pacemaker support. It ensures consistent and programmable pacing to maintain sustained cardiac function by stimulating the heart when its natural rhythm is insufficient. This makes it suitable for patients with bradycardia or other conditions requiring artificial cardiac pacing.

• Is the Model 325T intended for reuse or is it meant to be implanted as a single-use device?

  The Model 325T is explicitly intended for single-use implantation. This means it is not designed to be removed, cleaned, or reused after surgery, aligning with standard practices for implantable pacemaker pulse generators to ensure patient safety and sterility.

• How is the Model 325T supplied, and what does this mean for handling and preparation before implantation?

  The Model 325T is supplied sterile, which means it is pre-sterilized and packaged to prevent contamination before use. This eliminates the need for additional sterilization procedures in the operating room, ensuring readiness for immediate implantation while maintaining aseptic conditions.

• What regulatory pathway was followed for the FDA clearance of the Model 325T, and what does this mean for its use in clinical practice?

  The Model 325T received FDA clearance through a 510(k) submission (K812358) with a *Substantially Equivalent (SESE)* determination, meaning it was deemed comparable to a legally marketed predicate device. This clearance confirms it meets FDA standards for safety and effectiveness as an Implantable Pacemaker Pulse-Generator, allowing its use in clinical practice under the specified indications for cardiovascular support.

• Are there any known limitations regarding MRI compatibility for the Model 325T, and what should clinicians consider before using it in patients?

  The available data does not specify the MRI safety profile for the Model 325T, meaning its compatibility with magnetic resonance imaging (MRI) is not documented. Clinicians should exercise caution and consult manufacturer guidelines or alternative imaging modalities when considering MRI for patients with this device implanted, as untested exposure could pose risks.