Model 3003 Unipolar Demand Cardiac Gen.

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

510(k) Number

K802588 ↗

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 Model 3003 Unipolar Demand Cardiac Generator and how does it differ from other pacemakers?

  The Model 3003 is designed as an implantable pacemaker that regulates heart rhythm by delivering electrical impulses only when the heart’s natural electrical activity drops below a preset threshold, a feature known as unipolar demand mode. This ensures pacing occurs only when necessary, maintaining consistent cardiac output for patients with bradycardia or conduction disorders. Unlike bipolar pacemakers, it uses a single electrode, which can influence its electrical behavior and MRI compatibility.

• Is the Model 3003 intended for reuse or single-use, and what storage guidelines should be followed?

  The Model 3003 is supplied sterile and explicitly intended for single-use only. Since it is implanted surgically, proper handling and adherence to manufacturer storage guidelines are critical to maintain sterility and functionality. Storage should follow the manufacturer’s instructions to preserve device integrity until implantation.

• What regulatory pathway was used for FDA clearance of this device, and what does that mean for clinicians?

  The Model 3003 received FDA clearance through a Traditional 510(k) pathway, classified as substantially equivalent (SESE) to a predicate device under product code DXY (Implantable Pacemaker Pulse-Generator). This means the FDA determined it meets the same performance standards as existing pacemakers, ensuring safety and effectiveness for cardiovascular applications. Clinicians can rely on this clearance as evidence of regulatory scrutiny.

• Does this device have any special considerations for MRI compatibility, and if so, how should patients be advised?

  The Model 3003 adheres to MRI safety standards for specific imaging protocols, though exact compatibility details (e.g., safe scan parameters) should be confirmed with the manufacturer. Patients should be instructed to consult their clinician before MRI procedures to ensure safe imaging conditions, as improper exposure could risk device malfunction or patient safety.