Arcolith 2000 Implantable Pacemaker Pulse-Generator

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

Full name

Arcolith 2000

510(k) Number

K791715 ↗

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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• ArcoBiolith Pacemaker Model

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• 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 clinical conditions is the Arcolith 2000 intended to manage, and how does it achieve this?

  The Arcolith 2000 is designed to manage chronic bradycardia or conduction disorders by regulating cardiac rhythm. It does this through electrical impulse delivery to the heart when spontaneous contractions are insufficient, ensuring consistent pacing for patients requiring long-term cardiac support.

• Is the Arcolith 2000 meant for repeated use, or is it a single-use implantable device?

  The Arcolith 2000 is explicitly intended for single-use implantation only. It is supplied sterile and must be handled with sterile techniques before use, ensuring patient safety and compliance with clinical best practices.

• What precautions should be taken when handling or using this device, particularly regarding MRI exposure?

  The Arcolith 2000 is not MRI-safe, meaning it should never be exposed to MRI environments. This is critical because MRI fields can interfere with the device’s function or cause harm to the patient. Always verify the absence of MRI exposure before and during use.

• How is the device supplied, and what storage conditions should be followed?

  The Arcolith 2000 is supplied sterile and intended for direct implantation by qualified healthcare professionals. While specific storage conditions aren’t detailed, standard sterile device protocols—such as protecting from contamination, extreme temperatures, and physical damage—should be followed to maintain integrity until use.

• What regulatory pathway does the Arcolith 2000 follow, and how does this affect its availability?

  The Arcolith 2000 was cleared via the FDA 510(k) pathway (K791715), with a decision of *Substantially Equivalent* under the Cardiovascular advisory committee. This means it was reviewed for safety and effectiveness against legally marketed predicate devices, ensuring compliance with FDA regulations (e.g., 870.3610) before clinical use.