Pacemaker & Cardiac Lead, Bipolar

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

510(k) Number

K771262 ↗

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

• Implantable Heart Lead Terminal Adapter

  Class II

  FDA 510(k) K790436 Active Cleared 14 May 1979

See all devices from Arco Medical Products Co. →

• What is the primary purpose of this bipolar pacemaker and cardiac lead system, and how does it function in the body?

  This device is designed to regulate abnormal heart rhythms by delivering controlled electrical impulses to the heart muscle. The bipolar pacemaker pulse-generator generates these impulses, while the associated cardiac lead transmits them directly to the heart tissue, helping to maintain proper heart rate and rhythm for patients with conditions like bradycardia or other arrhythmias.

• Is this device intended for reuse, or is it meant for single-use implantation only?

  The device is supplied sterile and explicitly intended for single-use implantation only. Reuse is not recommended, as it could compromise sterility and device functionality, potentially risking patient safety.

• What storage and handling precautions must be followed to ensure the device remains effective and safe for use?

  Since the device is sterile, it must be stored and handled according to sterile medical device protocols to preserve its integrity. This includes keeping it in its original packaging, avoiding contamination, and adhering to manufacturer guidelines for shelf life and environmental conditions (e.g., temperature, humidity). Improper storage could compromise sterility and performance.

• How is this device regulated in the U.S., and what does the FDA’s classification mean for its use?

  This device is classified as a Class III medical device under FDA regulations, requiring pre-market approval due to its life-sustaining or life-supporting functions. It has received FDA 510(k) clearance (K771262), meaning it has been deemed *substantially equivalent* to a legally marketed predicate device. The regulatory classification (product code DXY, code 870.3610) confirms its use as an implantable pacemaker pulse-generator and associated lead.

• Are there different sizes or models available for this pacemaker and lead system, or is it a single configuration?

  The provided data does not specify distinct sizes or models beyond the bipolar pacemaker & cardiac lead system designation. However, the OpenFDA registration numbers suggest multiple FEI (Facility Establishment Identifier) records, which may indicate variations in lead lengths, electrode configurations, or pulse-generator programming options. For exact sizing or model-specific details, consult the manufacturer’s technical documentation or catalog.