Pulse Generator, Unipolar, Programable

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

510(k) Number

K772238 ↗

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 clinical conditions is this pulse generator designed to address in patients?

  This programmable, unipolar pulse generator is intended for patients experiencing intermittent or continuous conduction disorders, such as bradycardia or heart block, where the heart’s natural electrical signals are insufficient to maintain an adequate rhythm. It provides electrical stimulation to regulate cardiac rhythm through programmable modes like triggered, inhibited, or asynchronous pacing to adapt to varying clinical needs.

• Is this device intended for reuse after implantation, or is it single-use?

  This pulse generator is explicitly designed for single-use only after implantation. Once placed within the body, it is not intended to be removed or reused, aligning with standard practices for implantable cardiac devices.

• How should the device be prepared for surgical implantation given its sterility status?

  The pulse generator is non-sterile prior to implantation, meaning it must be sterilized by the healthcare professional performing the procedure. Sterilization is a critical step to ensure safety before the device is introduced into the patient’s body during surgery.

• What types of pacing modes does this device support, and how does that benefit patients?

  This device supports programmable pacing modes, including triggered, inhibited, and asynchronous pacing. These modes allow clinicians to tailor stimulation to the patient’s specific cardiac needs, improving adaptability for conditions like bradycardia or heart block where pacing requirements may vary over time.

• What regulatory pathway was followed for this device’s approval, and what does that mean for its use?

  The device was cleared through the FDA 510(k) pathway under the classification of Class III (DXY) for cardiovascular devices, adhering to 21 CFR 870.3610. This means it was deemed substantially equivalent to a predicate device and meets stringent regulatory standards for safety and effectiveness in managing cardiac rhythm disorders. The clearance does not imply MRI safety or reusable specifications.