Bipolar Cardiac Pulse Generator with Telemetry

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

510(k) Number

K854919 ↗

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 clinical conditions is this device designed to address and how does it work?

  This device is designed for patients with bradycardia or conduction disorders, where the heart beats too slowly or irregularly. It functions as an implantable pacemaker that delivers bipolar electrical pulses to regulate cardiac rhythm, ensuring proper heart function. The telemetry feature allows remote monitoring of device performance and patient status, enabling timely clinical intervention when needed.

• Is this device intended for reuse or single-patient use, and how should it be handled?

  This device is intended for single-patient use only. It is supplied sterile and must be handled according to sterile medical device protocols to maintain its integrity and functionality. Reuse is not recommended or approved for this device.

• What regulatory pathway was followed for this device’s clearance, and which advisory committee was involved?

  This device followed the FDA’s traditional 510(k) clearance pathway, classified as substantially equivalent under the Cardiovascular advisory committee. The clearance number is K854919, and it was reviewed under the product code DXY for Implantable Pacemaker Pulse-Generators.

• Can this device be used in patients who require MRI scans, and if not, what are the implications?

  The device data does not specify MRI safety information, meaning it is not labeled as MRI-safe or MRI-conditional. Patients with this implanted device should avoid MRI scans unless explicitly cleared by the manufacturer or a healthcare provider, as unapproved MRI exposure could pose risks to the device or patient.

• How is this device supplied, and what storage considerations should be taken into account?

  The device is supplied sterile and intended for single-patient use. Storage must comply with sterile medical device protocols to preserve its functionality. It should be stored in a clean, dry environment, protected from physical damage, and kept within the manufacturer’s recommended temperature and humidity ranges, though those specifics are not detailed in the provided data.