Microthin-PI Bipolar Pulse Generator

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

510(k) Number

K802410 ↗

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 purpose of the Microthin-PI Bipolar Pulse Generator, and how does its bipolar technology contribute to its function?

  The Microthin-PI Bipolar Pulse Generator is designed to serve as an implantable pacemaker, delivering precise electrical pulses to regulate cardiac rhythm when the heart’s natural pacing system is insufficient. Its bipolar technology ensures focused stimulation by using two electrodes, which improves pacing efficiency and reduces the risk of diaphragmatic stimulation or other unintended muscle contractions, thereby enhancing the accuracy of heart rhythm management.

• Is the Microthin-PI Bipolar Pulse Generator intended for reuse, or is it supplied sterile for single-use only?

  The device is explicitly supplied sterile for single-use only, as stated in its description. This ensures patient safety by preventing cross-contamination and maintaining sterility during implantation.

• What regulatory pathway was followed for the FDA clearance of this device, and what class does it fall under?

  The Microthin-PI Bipolar Pulse Generator received FDA clearance through a 510(k) submission, classified as Traditional, and was determined to be Substantially Equivalent to a predicate device. It is categorized under Class III, regulated under 21 CFR 870.3610, reflecting its role as an implantable pacemaker pulse generator with higher risk considerations.

• How many unique registration numbers are associated with this device in the FDA’s database, and what does this indicate?

  The device has 25 unique registration numbers listed in the FDA database (e.g., 2017865, 3005334138, etc.), which correspond to different manufacturing lots or production runs. This reflects its long-standing presence in the market and compliance with FDA tracking requirements for implantable devices.

• Where was this device originally manufactured, and what historical context does the manufacturer provide?

  The Microthin-PI Bipolar Pulse Generator was manufactured by Cardiac Pacemakers, Inc., with historical operations based in McHenry, Illinois (803 N. Front St., Suite 3, 60050). The company’s listing in the FDA records confirms its role as the applicant for the 510(k) clearance (K802410), filed in 1980, indicating its early adoption in pacemaker technology.