Pulse Generator, Bipolar, Programmable

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

510(k) Number

K772239 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Acuity Universal Cutter

  Class II

  FDA 510(k) K080154 Active Cleared 20 Mar 2008

• Pacemaker Programmer #2010

  Class III

  FDA 510(k) K811217 Active Cleared 20 Jul 1981

• Microthin-Pii Bipolar Pulse Gen. #0623

  Class III

  FDA 510(k) K803034 Active Cleared 22 Dec 1980

• Astra 2, 3, 4 and 6: Chip Revision

  Not classified

  FDA 510(k) K863000 Active Cleared 19 Aug 1986

• Command Ultra I Implantable Pacemaker Pulse-Generator

  Class III

  FDA 510(k) K831161 Active Cleared 15 Jun 1983

• Elgiloy Stylet

  Class II

  FDA 510(k) K770243 Active Cleared 14 Feb 1977

See all devices from Cardiac Pacemakers, Inc. →

• What is the primary purpose of this bipolar, programmable pulse generator, and how does its design benefit patients?

  This pulse generator is designed to regulate heart rhythm by delivering precise electrical impulses to the heart muscle, specifically for patients with bradycardia or conduction disorders. The bipolar design ensures targeted energy delivery, minimizing the risk of unintended stimulation to surrounding tissues, which improves safety and effectiveness during pacing.

• Is this device intended for reuse, or is it meant for single-patient use only? How should it be handled to maintain sterility?

  This pulse generator is intended for single-patient use only and is supplied sterile for surgical implantation. It must be handled under aseptic conditions to preserve sterility before use, as per manufacturer guidelines.

• What regulatory pathway does this device follow, and what does its classification mean for safety standards?

  This device follows the FDA’s 510(k) clearance pathway (K772239) and is classified as a Class III medical device, indicating it is subject to stringent regulatory oversight due to its role in life-sustaining or life-supporting functions. The clearance confirms compliance with safety and performance standards for cardiovascular devices.

• How should this device be stored before implantation to ensure proper functionality?

  The device must be stored and handled according to the manufacturer’s guidelines to maintain both sterility and functionality. Since it is supplied sterile for surgical use, adherence to aseptic practices is critical to prevent contamination before implantation.