Microthin-PI

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

510(k) Number

K800027 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Acuity Universal Cutter

  Class II

  FDA 510(k) K080154 Active Cleared 20 Mar 2008

• Pacemaker Programmer #2010

  Class III

  FDA 510(k) K811217 Active Cleared 20 Jul 1981

• Microthin-Pii Bipolar Pulse Gen. #0623

  Class III

  FDA 510(k) K803034 Active Cleared 22 Dec 1980

• Astra 2, 3, 4 and 6: Chip Revision

  Not classified

  FDA 510(k) K863000 Active Cleared 19 Aug 1986

• Command Ultra I Implantable Pacemaker Pulse-Generator

  Class III

  FDA 510(k) K831161 Active Cleared 15 Jun 1983

• Elgiloy Stylet

  Class II

  FDA 510(k) K770243 Active Cleared 14 Feb 1977

See all devices from Cardiac Pacemakers, Inc. →

• What is the primary clinical purpose of the Microthin-PI Implantable Pacemaker Pulse-Generator, and who is it designed for?

  The Microthin-PI is designed to regulate abnormal heart rhythms by delivering electrical impulses to the heart muscle. It is specifically intended for patients with bradycardia (slow heart rate) or other conduction disorders requiring chronic cardiac pacing. This makes it suitable for use in clinical settings where patients need long-term pacing support for stable heart function.

• Is the Microthin-PI a single-use or reusable device, and how does this affect its use in clinical settings?

  The Microthin-PI is explicitly described as a reusable implantable system. This means it is intended for repeated use after proper cleaning, sterilization, and maintenance—unlike single-use devices—which is important for cost efficiency and inventory management in cardiovascular clinics or operating rooms where multiple procedures may be performed.

• What regulatory pathway was followed for the FDA clearance of the Microthin-PI, and what does this mean for its use in the U.S.?

  The Microthin-PI was cleared through the FDA 510(k) process, specifically under Traditional Review and classified as Substantially Equivalent (SESE) to a predicate device. This means its safety and effectiveness were compared to an existing, legally marketed device, ensuring compliance with 21 CFR 870.3610—the regulatory standard for implantable pacemaker pulse-generators. Clinicians can rely on this clearance as evidence of its regulatory validation for use in the U.S.

• Are there any special storage or handling requirements for the Microthin-PI before implantation?

  The provided data does not specify any unique sterility or storage requirements beyond standard practices for implantable medical devices. Since it is reusable, proper cleaning, sterilization (e.g., autoclave or ethylene oxide), and storage in a clean, dry environment—protected from contamination—are critical before reuse. Clinicians should follow manufacturer guidelines for maintenance to ensure device integrity and patient safety.

• What types of clinical settings or specialties would most commonly use the Microthin-PI, and why?

  The Microthin-PI is categorized under Cardiovascular medical specialty and regulated for use in settings where chronic cardiac pacing is required. This includes electrophysiology labs, cardiac catheterization suites, and hospitals with dedicated cardiac surgery units. Its design aligns with procedures for patients with bradycardia or conduction disorders, making it a tool for cardiologists, electrophysiologists, and cardiac surgeons who manage complex heart rhythm disorders.