Cyberlith Implantable Pulse Gen. #253-04

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K800645 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Lifeline Unipolar Lead #487-05

  Class III

  FDA 510(k) K823508 Active Cleared 14 Jan 1983

• Implant Aid Splicing Crimp & Sleeve

  Class III

  FDA 510(k) K813518 Active Cleared 12 Jan 1982

• Veri-Vu Lensometer

  Class I

  FDA 510(k) K791521 Active Cleared 30 Oct 1979

• Implantable Pulse Generator Pacemakers

  Class III

  FDA 510(k) K791568 Active Cleared 19 Sep 1979

• Model 480-01 Pacing Lead

  Class III

  FDA 510(k) K844270 Active Cleared 28 Mar 1985

• GE Lead Adapter, Model 345-01

  Class II

  FDA 510(k) K801040 Active Cleared 30 Jun 1980

See all devices from Intermedics, Inc. →

• What is the primary clinical purpose of the Cyberlith Implantable Pulse Generator Model 253-04, and which patient populations does it support?

  The Cyberlith Implantable Pulse Generator Model 253-04 is designed to regulate cardiac rhythm by delivering electrical impulses to the heart, specifically for patients requiring chronic pacing support due to bradycardia or conduction disorders. It provides programmable stimulation to maintain proper heart function in individuals with persistent slow heart rates or electrical signal transmission issues.

• Is this device intended for single-use or can it be reused in clinical settings, and what considerations apply?

  The Cyberlith Implantable Pulse Generator Model 253-04 is supplied sterile and intended for single-use implantation. However, it may be reusable under specific clinical protocols, though this would require adherence to strict sterile handling and reprocessing guidelines to ensure patient safety and device integrity.

• How should the Cyberlith Implantable Pulse Generator Model 253-04 be stored, and why is this important?

  The device must be stored and handled according to sterile medical device protocols to maintain its integrity and ensure patient safety. Proper storage conditions prevent contamination and preserve functionality, which is critical for an implantable device intended for chronic use.

• What regulatory pathway was followed for the Cyberlith Implantable Pulse Generator Model 253-04, and which advisory committee was involved?

  The Cyberlith Implantable Pulse Generator Model 253-04 was cleared through the FDA’s 510(k) pathway (K800645) under the product code DXY, classified as a Class III device. The submission was reviewed by the Cardiovascular (CV) Advisory Committee, reflecting its classification as an Implantable Pacemaker Pulse-Generator.