Microthin-P1 (Mod. 0622)

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

510(k) Number

K801121 ↗

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-P1 (Mod. 0622) pacemaker, and how does it function in clinical practice?

  The Microthin-P1 (Mod. 0622) is designed to regulate cardiac rhythm by delivering controlled electrical impulses to the heart, specifically for managing life-threatening arrhythmias. It is an implantable pulse-generator, meaning it is surgically placed under the skin to continuously monitor and stimulate the heart as needed, ensuring proper pacing when the heart’s natural rhythm is compromised.

• Is the Microthin-P1 (Mod. 0622) intended for reuse, or is it meant for single-use only?

  The Microthin-P1 (Mod. 0622) is supplied sterile and explicitly intended for single-use only. Since it is an implantable device, it must remain uncontaminated to prevent infection or complications during or after implantation, which is why it is not designed for reuse.

• What storage conditions should be followed for the Microthin-P1 (Mod. 0622) to maintain its sterility and functionality?

  While the exact storage instructions are not detailed in the provided data, the device is supplied sterile for surgical use. As a best practice for implantable medical devices, it should be stored in a clean, dry environment, protected from physical damage, extreme temperatures, and contamination until use. Always follow the manufacturer’s specific packaging guidelines to preserve sterility.

• How is the regulatory approval status of the Microthin-P1 (Mod. 0622) defined, and what does this mean for clinicians?

  The Microthin-P1 (Mod. 0622) holds an FDA 510(k) clearance (K801121), meaning it has been deemed substantially equivalent to a legally marketed device already on the market. This clearance confirms that the device meets FDA safety and effectiveness requirements for its intended use in regulating cardiac rhythm. Clinicians can rely on this approval as evidence of regulatory scrutiny before clinical implementation.