Cardiac Pulse Generator 254-18

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K841074 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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See all devices from Intermedics, Inc. →

• What is the primary clinical purpose of the Cardiac Pulse Generator 254-18 and how does it function in the body?

  The Cardiac Pulse Generator 254-18 is designed to regulate and maintain the heart’s electrical activity by delivering timed electrical impulses. It is intended for patients with bradycardia or conduction disorders, stimulating cardiac contractions to ensure proper heart rhythm when the natural electrical system is impaired.

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

  This device is explicitly supplied sterile for surgical implantation and is intended for single-patient use only. Due to its implantable nature and regulatory classification, it must be handled in a controlled clinical environment to ensure patient safety and sterility.

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

  The Cardiac Pulse Generator 254-18 was cleared through the FDA’s 510(k) process (K841074) as a Class III device, which requires premarket approval due to its high-risk, life-sustaining nature. This clearance confirms it meets FDA standards for safety and effectiveness as an implantable pacemaker pulse-generator, ensuring it can be legally implanted in patients under medical supervision.

• How is the device supplied, and what precautions should be taken during handling?

  The device is supplied sterile and packaged for surgical implantation, meaning it must remain unopened until use in a controlled clinical setting. Since it is intended for single-patient use, proper aseptic techniques must be followed during handling to prevent contamination, and it should only be implanted by trained medical professionals.