Modification of Sterility Cycle Parameters (K863365)

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

Full name

Modification of Sterility Cycle Parameters

510(k) Number

K863365 ↗

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 type of device is this modification related to, and how is it used clinically?

  This modification pertains to an Implantable Pacemaker Pulse-Generator, a Class III medical device used in cardiovascular procedures. The device is implanted to regulate heart rhythms by delivering electrical impulses when the heart’s natural pacemaker isn’t functioning properly. The sterilization adjustments ensure the device remains safe and sterile for implantation, maintaining its integrity for long-term use in patients.

• Is this device single-use or reusable, and how is it sterilized?

  This device is reusable, as explicitly stated in the submission. The modification involves adjustments to the sterilization cycle parameters to ensure it meets strict sterility standards (per FDA regulation 870.3610) before reuse in cardiovascular procedures. The validated process guarantees consistent sterility assurance for repeated use.

• What regulatory pathway was followed for this modification, and which advisory committee reviewed it?

  This modification was submitted under the FDA 510(k) pathway (clearance number K863365) and underwent traditional review by the FDA’s Cardiovascular (CV) Advisory Committee. The submission was classified as substantially equivalent (SESE) and filed under product code DXY, confirming compliance with regulatory requirements for implantable cardiovascular devices.

• How many different models or versions of this device are associated with this modification?

  This modification applies to multiple versions of an Implantable Pacemaker Pulse-Generator, as indicated by the 18 distinct FEI numbers (e.g., 3002807576, 2017865, etc.) listed in the submission. Each FEI represents a unique device variant, all of which benefit from the updated sterilization cycle to maintain sterility and safety for reuse.