Microthin-DI Bipolar Pulse Generator

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

510(k) Number

K802409 ↗

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-DI Bipolar Pulse Generator, and how does its bipolar design benefit patients?

  The Microthin-DI Bipolar Pulse Generator is designed to deliver precise electrical impulses for cardiac pacing, helping patients with bradycardia or conduction disorders maintain a normal heart rhythm. Its bipolar technology ensures targeted stimulation of the heart, reducing the risk of unintended muscle stimulation and improving pacing accuracy compared to unipolar systems.

• Is this device intended for reuse, or is it meant to be implanted as a single-use device?

  The Microthin-DI Bipolar Pulse Generator is supplied in sterile packaging, which indicates it is intended for single-use implantation only. Reuse is not recommended or supported by the manufacturer’s specifications.

• How was this device’s regulatory pathway determined, and what does the product code (DXY) signify?

  The device was cleared via a Traditional 510(k) pathway in 1980 (K802409) and is classified as a Class 3 Cardiovascular device under FDA regulations. The product code DXY categorizes it as an *Implantable Pacemaker Pulse-Generator*, reflecting its intended use in treating bradycardia or conduction disorders.

• What storage or handling precautions should be taken with this device before implantation?

  Since the Microthin-DI Bipolar Pulse Generator is supplied in sterile packaging, it must be stored according to manufacturer guidelines to preserve sterility—typically in a clean, dry environment away from direct sunlight or extreme temperatures. Always follow the included instructions for proper handling to ensure device integrity before use.