Cook Pacemaker Corp. 332T Bipolar Cardiac Pulse GE

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

510(k) Number

K851699 ↗

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 Cook Pacemaker Corp. 332T Bipolar Cardiac Pulse Generator, and how does it function in clinical settings?

  The Cook Pacemaker Corp. 332T Bipolar Cardiac Pulse Generator is designed to regulate cardiac rhythm by delivering electrical impulses to the heart. It serves as an implantable pacemaker pulse-generator, specifically for treating bradycardia or other cardiac conduction disorders. By continuously monitoring heart rate and delivering timed electrical stimuli, it helps maintain a stable and effective heartbeat when the heart’s natural conduction system is impaired.

• Is this device intended for single-use or reusable implantation, and what does that mean for clinical workflows?

  This device is explicitly intended for single-use implantation, meaning it is not designed to be removed, cleaned, or reused after one procedure. Clinicians must use a new unit per patient, which ensures sterility and reduces infection risks. This also means inventory management must account for one-time use, and reprocessing or sterilization is not applicable.

• How is the device supplied, and what should clinicians verify before use to ensure proper handling?

  The device is supplied sterile and packaged for direct implantation, eliminating the need for additional sterilization steps. Clinicians should verify the sterile packaging integrity before opening and confirm the device’s compatibility with the patient’s clinical needs (e.g., pacing requirements). Since it’s single-use, proper disposal protocols must also be followed post-implantation.

• What regulatory pathway does this device follow, and how does that affect its availability or approval status?

  The device follows the FDA 510(k) clearance pathway, classified as *Substantially Equivalent* to a predicate device under 21 CFR 870.3610. This means it has undergone FDA review and is considered safe and effective for its intended use, though the exact approval status (e.g., cleared for sale) is tied to the FDA’s decision records. Clinicians can confirm its regulatory status via the FDA’s device database using the K-number (K851699) or product code (DXY).

• Are there multiple models or sizes available for this device, or is it a fixed specification for all patients?

  The provided data does not specify variable models or sizes for the 332T Bipolar Cardiac Pulse Generator, implying it is a standardized unit designed for general use in bradycardia or conduction disorder cases. If size or programming features are critical for a patient, clinicians should consult the manufacturer’s documentation or confirm compatibility with the specific pacing leads being used. No size variations are mentioned in the regulatory records.