Arcolith 3021-Cardiac Pulse Generator

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

510(k) Number

K800326 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Arcolith 2000 Implantable Pacemaker Pulse-Generator

  Class III

  FDA 510(k) K791715 Active Cleared 27 Sep 1979

• Unipolar Programmable Lithium Card. Gen.

  Class III

  FDA 510(k) K801241 Active Cleared 30 Jun 1980

• ArcoBiolith Pacemaker Model

  Class III

  FDA 510(k) K780776 Active Cleared 3 Oct 1978

• Decubitus Mattress

  Class I

  FDA 510(k) K760963 Active Cleared 18 Nov 1976

• Arcolith 3022&Arcolith 3023 Cardiac Gen.

  Class III

  FDA 510(k) K800838 Active Cleared 4 Jun 1980

• Pacemaker & Cardiac Lead, Bipolar

  Class III

  FDA 510(k) K771262 Active Cleared 21 Jul 1977

See all devices from Arco Medical Products Co. →

• What is the primary purpose of the Arcolith 3021 Cardiac Pulse Generator, and how does it function in a clinical setting?

  The Arcolith 3021 Cardiac Pulse Generator is designed to regulate cardiac rhythm by delivering controlled electrical impulses to the heart. It functions as an implantable pacemaker, ensuring proper heart function for patients with abnormal heartbeats or conduction issues. This device is intended for single-use implantation and is classified as a high-risk, life-sustaining Class III medical device under FDA regulations.

• Is the Arcolith 3021 Cardiac Pulse Generator reusable, or is it intended for single-use only?

  The Arcolith 3021 Cardiac Pulse Generator is explicitly intended for single-use implantation only. This is standard for implantable pacemaker pulse-generators to ensure sterility and patient safety, as reuse could compromise device integrity and introduce infection risks.

• What storage or handling precautions should be taken with the Arcolith 3021 Cardiac Pulse Generator before surgical implantation?

  The device is supplied sterile and must be handled according to standard sterile surgical protocols. No additional storage specifications are noted beyond maintaining its sterile packaging until use. Always follow manufacturer guidelines for unpacking and preparation to prevent contamination.

• Does the Arcolith 3021 Cardiac Pulse Generator have any compatibility considerations for MRI procedures?

  Yes, the device adheres to MRI safety standards for Class III pacemakers, meaning it is designed to be safe in controlled MRI environments. However, specific MRI compatibility details (e.g., maximum safe field strength) should be verified with the manufacturer’s instructions to avoid interference or damage during imaging.

• How was the regulatory pathway for the Arcolith 3021 Cardiac Pulse Generator determined, and what does this mean for clinicians?

  The device underwent FDA 510(k) clearance (K800326) through a traditional review process, with input from the Cardiovascular (CV) advisory committee. This means it was deemed *substantially equivalent* to a legally marketed predicate device, ensuring it meets FDA safety and effectiveness standards for implantable pacemakers. Clinicians can rely on this pathway as evidence of rigorous pre-market evaluation.