Arcolith 2100-Cardiac Pulse Generator

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

510(k) Number

K792216 ↗

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 Arco Medical Products Co. →

• What is the primary purpose of the Arcolith 2100-Cardiac Pulse Generator, and who should use it?

  The Arcolith 2100-Cardiac Pulse Generator is designed to regulate heart rhythm by delivering electrical impulses, specifically for patients with bradycardia or other cardiac conduction disorders. It is intended for use in cardiac pacing applications to maintain proper heart function and is meant to be implanted by qualified healthcare professionals in clinical settings where cardiac pacing procedures are performed.

• Is the Arcolith 2100-Cardiac Pulse Generator reusable, or is it meant for single-use only?

  The device is explicitly supplied as a sterile, single-use implantable component. This means it is intended for one-time surgical implantation and should not be reused after initial use, adhering to standard sterile medical device protocols.

• How should the Arcolith 2100-Cardiac Pulse Generator be stored, and what precautions should be taken?

  Since the device is sterile and single-use, it must be stored and handled according to sterile medical device protocols to ensure its integrity and safety. Storage conditions should prevent contamination and maintain the device’s readiness for surgical implantation in authorized clinical settings.

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

  The Arcolith 2100-Cardiac Pulse Generator was cleared through the FDA’s 510(k) process, specifically under the traditional clearance type with a decision code of SESE (Substantially Equivalent). The review was conducted by the Cardiovascular (CV) Advisory Committee, reflecting its classification as a Class III device for cardiac pacing applications.

• What are the key details about the manufacturer and the device’s regulatory filing history?

  The device is manufactured by Arco Medical Products Co., located at 803 N. Front St. Suite 3, McHenry, IL 60050. It was originally filed with the FDA on November 5, 1979, and received clearance on November 29, 1979, under the 510(k) number K792216. The device falls under the product code DXY and is regulated under FDA regulation number 870.3610.