Elecath Torkfloat Pacing Probe

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

510(k) Number

K850065 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Multipace

  Class II

  FDA 510(k) K934785 Active Cleared 27 Jul 1995

• Elecath(R) Transesophageal Pacing Catheter

  Class II

  FDA 510(k) K874154 Active Cleared 29 Apr 1988

• Elecath Portal Vein/Biliary Drain Assm

  Class I

  FDA 510(k) K821488 Active Cleared 28 May 1982

• Elecath Heparin-Coated Catheters

  Class II

  FDA 510(k) K841615 Active Cleared 5 Jun 1984

• Elecath Infant Arterial & Venous Cannu

  Class II

  FDA 510(k) K842369 Active Cleared 27 Aug 1984

• Pacing Kit, Semi-Floating

  Class II

  FDA 510(k) K770018 Active Cleared 14 Jan 1977

See all devices from Electro-Catheter Corp. →

• What is the primary purpose of the Elecath Torkfloat Pacing Probe and how does it function in the body?

  The Elecath Torkfloat Pacing Probe is designed as a permanent pacemaker electrode implanted in the cardiovascular system to deliver electrical stimulation. It regulates heart rhythm in patients with bradycardia or conduction disorders, ensuring consistent and reliable cardiac function by pacing the heart when natural electrical signals are insufficient.

• Is the Elecath Torkfloat Pacing Probe intended for single-use or reusable applications, and how is it supplied?

  The device is sterile at time of supply and explicitly intended for single-use implantation only. It comes pre-packaged for direct surgical use without reprocessing, adhering to medical device sterility standards for cardiovascular procedures.

• What regulatory pathway and advisory committee were involved in the FDA clearance of this device?

  The Elecath Torkfloat Pacing Probe was cleared via the Traditional 510(k) pathway with substantially equivalent determination (decision code: SESE). Its review was conducted by the Cardiovascular (CV) Advisory Committee, reflecting its classification under FDA device class 3 (regulation number 870.3680) for permanent pacemaker electrodes.

• Does this device come in multiple sizes or models, and if so, how would a clinician determine the appropriate selection?

  The provided data lists multiple FEI numbers (e.g., 3002618605, 1028232), which typically correspond to different product variants or lot identifiers rather than distinct physical sizes or models. While exact sizing details aren’t specified, the probe is engineered for precise cardiovascular implantation, and selection would rely on manufacturer guidelines or surgeon preference based on patient anatomy and pacing requirements.