C-101-P Implantable Pacemaker Pulse-Generator

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

Full name

C-101-P

510(k) Number

K820939 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Endo-Lok L-40 Endocardial Pacing Electrode

  Class III

  FDA 510(k) K760714 Active Cleared 14 Dec 1976

• Coratomic #VX5-105 & VX5-205 Pulse Gen.

  Class III

  FDA 510(k) K822791 Active Cleared 15 Dec 1982

• L-15T Endocardial Pacing Electrode

  Not classified

  FDA 510(k) K802689 Active Cleared 28 Oct 1980

• Ovalith-920

  Class III

  FDA 510(k) K810808 Active Cleared 15 May 1981

• Endocardial Pacing Electrode

  Class III

  FDA 510(k) K772309 Active Cleared 6 Feb 1978

• OVALITH-300 Implantable Pacemaker Pulse-Generator

  Class III

  FDA 510(k) K790446 Active Cleared 30 Jul 1979

See all devices from Coratomic, Inc. →

• What is the primary purpose of the C-101-P Implantable Pacemaker Pulse-Generator, and how does it function in a clinical setting?

  The C-101-P is designed to regulate abnormal heart rhythms by delivering controlled electrical impulses to the heart muscle, acting as the power source and control unit for pacemaker systems. It ensures consistent cardiac pacing when the heart’s natural conduction system fails to maintain a proper rhythm, making it essential for patients with bradycardia or other conduction disorders.

• Is the C-101-P intended for single-use or reusable applications, and what sterility precautions should be taken?

  The C-101-P is supplied sterile and intended for single-patient use only. Since it is implanted surgically, it must be handled under strict sterile medical device protocols to prevent contamination before and during implantation.

• How is the regulatory status of the C-101-P determined, and what does this mean for healthcare providers?

  The C-101-P is regulated under FDA 510(k) clearance (K820939) and classified as substantially equivalent to prior devices. This means it has undergone FDA review by the Cardiovascular Advisory Committee and meets the requirements of 21 CFR 870.3610 for pacemaker pulse-generators, ensuring it adheres to safety and performance standards for clinical use.

• What type of surgical setting or procedure is required for the implantation of the C-101-P?

  The C-101-P is designed for surgical implantation, meaning it requires a sterile operating environment and specialized medical personnel to place it within the patient’s body. The procedure typically involves precise placement of the pulse-generator to ensure proper function and patient safety.