Micropulse 26U Pulse Generator

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

510(k) Number

K771987 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Edwards Pacemaker 30 Unipolar Generator

  Class III

  FDA 510(k) K791751 Active Cleared 26 Sep 1979

• Micropulse 22S Pacemaker

  Class III

  FDA 510(k) K780780 Active Cleared 30 Jun 1978

• Prolith 23S Pacemaker

  Class III

  FDA 510(k) K781042 Active Cleared 27 Jul 1978

• Generator, Pulse, Cardiac 2LU

  Class III

  FDA 510(k) K770657 Active Cleared 26 Apr 1977

• Micropulse 22U

  Class III

  FDA 510(k) K780091 Active Cleared 30 Jan 1978

• Analyzer, Pacer System, Psa-5

  Class II

  FDA 510(k) K781144 Active Cleared 23 Aug 1978

See all devices from Edwards Pacemaker Systems →

• What is the primary purpose of the Micropulse 26U Pulse Generator in a clinical setting?

  The Micropulse 26U Pulse Generator is designed to regulate cardiac rhythm by delivering electrical impulses to the heart, specifically for patients with bradycardia or conduction disorders. It ensures consistent and reliable cardiac function by providing pacing support in a controlled clinical environment.

• Is the Micropulse 26U Pulse Generator intended for single-use or can it be reused?

  The Micropulse 26U Pulse Generator is supplied as a reusable component within a pacemaker system. It is not sterile as shipped and must be handled in a sterile surgical setting during implantation by qualified healthcare professionals.

• How is the regulatory pathway for this device structured, and what does it indicate about its risk level?

  The Micropulse 26U Pulse Generator is classified as a Class III medical device and has obtained FDA 510(k) clearance under the traditional review pathway, with a decision code of 'SESE' (Substantially Equivalent). This classification and clearance indicate it is a high-risk, life-sustaining cardiovascular device, ensuring stringent regulatory oversight for patient safety.

• What type of medical specialty is primarily responsible for the use and oversight of this device?

  The Micropulse 26U Pulse Generator falls under the medical specialty of Cardiovascular, meaning it is primarily used and overseen by cardiologists, electrophysiologists, and other specialists in cardiac care who manage pacemaker therapy.

• What does the product code (DXY) and advisory committee designation (CV) signify for this device?

  The product code DXY categorizes this device as an Implantable Pacemaker Pulse-Generator under FDA’s classification system, while the advisory committee designation (CV) indicates it was reviewed by the Cardiovascular (CV) Panel during the 510(k) submission process. This reflects its specialized role in cardiac pacing and the expertise involved in its regulatory evaluation.