Arcolith 3020-Cardiac Pulse Generator

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

510(k) Number

K792299 ↗

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 clinical purpose of the Arcolith 3020-Cardiac Pulse Generator, and how does it achieve this?

  The Arcolith 3020-Cardiac Pulse Generator is designed to regulate heart rhythm in patients with bradycardia or conduction disorders by delivering electrical impulses. It ensures consistent cardiac function through surgical implantation, acting as an implantable pacemaker pulse-generator.

• Is the Arcolith 3020-Cardiac Pulse Generator intended for reuse, or is it meant for single-use after implantation?

  The device is explicitly designed for single-use implantation, as stated in its specifications. It is supplied sterile and intended to be implanted once, without any indication of reuse.

• What regulatory pathway was followed for the FDA clearance of the Arcolith 3020-Cardiac Pulse Generator, and what does this classification imply?

  The device was cleared through the FDA’s 510(k) pathway under the classification of a Class III medical device, which is reserved for high-risk devices like cardiovascular implants. The clearance type is traditional, and it was determined to be substantially equivalent to a predicate device, ensuring compliance with regulation number 870.3610.

• Does the Arcolith 3020-Cardiac Pulse Generator have any special considerations for storage or handling before implantation?

  While the provided data does not specify storage conditions, the device is supplied sterile and intended for surgical implantation. Standard sterile handling procedures for implantable medical devices should be followed to maintain its integrity until use.

• What medical specialty is primarily responsible for the use of the Arcolith 3020-Cardiac Pulse Generator?

  The device falls under the medical specialty of cardiovascular care, as indicated by its classification and regulatory filings. Cardiologists and cardiac surgeons are the primary clinicians involved in its implantation and management.