Generator, Pulse, Cardiac 2LU

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

510(k) Number

K770657 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Micropulse 26U Pulse Generator

  Class III

  FDA 510(k) K771987 Active Cleared 2 Nov 1977

• 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

• 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 GENERATOR, PULSE, CARDIAC 2LU, and who should use it?

  The GENERATOR, PULSE, CARDIAC 2LU is designed to regulate cardiac rhythm by delivering electrical impulses to the heart for patients with bradycardia or conduction disorders requiring chronic pacing support. It is intended for qualified healthcare professionals to implant in clinical settings only, ensuring consistent stimulation to maintain normal heart function.

• Is this device sterile and intended for single-use, or can it be reused?

  Yes, the GENERATOR, PULSE, CARDIAC 2LU is supplied sterile and explicitly intended for single-use implantation. Reuse is not permitted, as it violates sterile medical device protocols and could compromise patient safety.

• How should this device be stored, and what precautions should be taken?

  Since it is a sterile, single-use implantable device, storage must follow strict sterile medical device protocols to preserve integrity. It should be kept in its original packaging, protected from contamination, and used only in controlled clinical environments by trained professionals.

• What regulatory pathway was followed for FDA clearance, and what does that mean for its use?

  The GENERATOR, PULSE, CARDIAC 2LU received FDA clearance via a Traditional 510(k) pathway (K770657) under product code DXY, classified as a Class III cardiovascular device. This means it was deemed substantially equivalent to a legally marketed predicate device and is regulated under 21 CFR 870.3610, ensuring compliance with strict safety and performance standards for implantable pacemakers.