Pulse Generator, Bipolar, Demand

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

510(k) Number

K772241 ↗

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 pulse generator in clinical practice?

  This bipolar, demand-type pulse generator is designed to regulate heart rhythm in patients with bradycardia or conduction disorders by delivering electrical impulses only when the patient’s intrinsic heart rate drops below a preset threshold. It ensures consistent cardiac pacing through a bipolar electrode configuration, activating only when needed to maintain proper heart function.

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

  This pulse generator is classified as a reusable, implantable component. While it is intended for permanent implantation within a patient, it requires sterile handling during surgical procedures to prevent infection. Reuse is not applicable post-implantation, as it is designed for long-term use within the body.

• What regulatory pathway was followed for FDA clearance of this device?

  This pulse generator received FDA clearance through a 510(k) submission, classified as Substantially Equivalent (SESE) under the Traditional review pathway. The decision was made by the Cardiovascular (CV) Advisory Committee in 1978, with the clearance number K772241. It falls under product code DXY and is categorized as a Class III medical device.

• Are there any special storage or handling instructions for this device?

  While the data does not specify exact storage conditions, as an implantable cardiac device, it must be handled under sterile conditions during surgical implantation to minimize infection risk. Storage and use should follow the manufacturer’s guidelines for implantable pacemaker pulse generators, which typically include protection from moisture, extreme temperatures, and physical damage.

• Does this device have any known restrictions on compatibility with MRI machines?

  The provided data does not mention any MRI safety restrictions for this pulse generator. However, as with all implantable cardiac devices, clinicians should verify compatibility with MRI procedures on a case-by-case basis, as MRI exposure can pose risks to pacemakers. Always consult the manufacturer’s latest guidelines or device labeling for updated safety information.