Command P5 Implantable Pacemaker Pulse-Generator

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

Full name

Command P5

510(k) Number

K813534 ↗

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 types of heart conditions is the Command P5 designed to treat, and how does it work?

  The Command P5 is designed for patients with bradycardia or conduction disorders that require chronic cardiac pacing. It regulates abnormal heart rhythms by delivering programmable electrical impulses to the heart muscle, helping restore normal heart function through adjustable pacing rates and modes.

• Is the Command P5 intended for reuse, or is it meant to be implanted once and discarded?

  The Command P5 is supplied sterile and intended for single-use implantation only. After use, it should not be reused, as this could compromise patient safety and device integrity.

• Can this device be safely used in an MRI environment, or are there specific precautions to consider?

  The Command P5 is MRI-unsafe, meaning it should never be exposed to MRI scanning. Its electronic components could be damaged by magnetic fields, posing risks to both the patient and the device.

• What storage conditions are required to maintain the device’s integrity before implantation?

  The Command P5 must be stored in a way that protects it from moisture and physical stress, as outlined in the manufacturer’s guidelines. Proper handling ensures the device remains functional for its intended use.

• How is the Command P5 regulated in the U.S., and what does its FDA clearance status indicate?

  The Command P5 holds FDA 510(k) clearance (K813534), meaning it has been determined to be substantially equivalent to a legally marketed predicate device. This clearance confirms it meets regulatory standards for implantable cardiac devices under 21 CFR 870.3610, ensuring safety and performance for its intended use.