Pacemaker, Model 229-01

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K781738 ↗

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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  FDA 510(k) K813518 Active Cleared 12 Jan 1982

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  Class I

  FDA 510(k) K791521 Active Cleared 30 Oct 1979

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  FDA 510(k) K801040 Active Cleared 30 Jun 1980

See all devices from Intermedics, Inc. →

• What is the primary purpose of the Pacemaker, Model 229-01, and how does it function in the body?

  The Pacemaker, Model 229-01, is designed to regulate heart rhythm by delivering electrical impulses to the heart muscle when the natural pacemaker fails. It is an implantable pulse-generator surgically placed in the body to ensure consistent heart contractions, which is critical for patients with life-threatening cardiac conditions where the heart’s natural rhythm is unreliable.

• Is the Pacemaker, Model 229-01, intended for reuse or single-use, and how should it be handled to maintain sterility?

  The Pacemaker, Model 229-01, is supplied sterile and intended for single-use only. Due to its critical role in patient safety, it must be handled under strict sterility protocols, adhering to controlled clinical settings to prevent contamination and ensure proper function after implantation.

• What regulatory pathway was followed for the FDA clearance of this device, and which advisory committee was involved?

  The Pacemaker, Model 229-01, was cleared through the FDA’s 510(k) pathway, specifically under the Traditional clearance type, with a decision of Substantially Equivalent. The device was reviewed by the Cardiovascular (CV) Advisory Committee, reflecting its classification as a Class III medical device due to its role in managing life-threatening cardiac conditions.

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

  The Pacemaker, Model 229-01, falls under the medical specialty of Cardiovascular care. This specialty encompasses the diagnosis and treatment of conditions affecting the heart and blood vessels, making it the primary focus for clinicians who implant, monitor, and manage patients using this device.