Pacing Kit, Semi-Floating

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

510(k) Number

K770018 ↗

FDA Product Code

DTR

Device Class

Class II

Regulation

21 CFR Part 870.4240

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

• Tip Deflector (Genesis)

  Class II

  FDA 510(k) K943257 Active Cleared 19 Apr 1995

See all devices from Electro-Catheter Corp. →

• What is the primary use of the Electro-Catheter Semi-Floating Pacing Kit?

  The Semi-Floating Pacing Kit is specifically designed for temporary cardiac pacing in patients requiring short-term rhythm regulation. This includes scenarios such as diagnostic procedures or transient arrhythmias where stable, acute pacing support is needed. The semi-floating electrode design minimizes tissue trauma while ensuring reliable pacing performance, making it ideal for high-acuity clinical environments.

• Is the Semi-Floating Pacing Kit sterile and single-use, and how should it be handled?

  Yes, the kit is supplied sterile and intended for single-use only. It must be handled according to strict sterile medical device protocols to maintain integrity and prevent contamination. Components like electrodes, leads, and pacing circuitry are pre-packaged for immediate deployment, ensuring readiness for clinical use without additional preparation.

• What components are included in the Semi-Floating Pacing Kit, and how does the semi-floating design benefit patients?

  The kit includes all necessary components for temporary pacing: electrodes, leads, and pacing circuitry. The semi-floating design ensures electrodes remain stably positioned within the heart while reducing the risk of tissue damage, which improves pacing reliability and patient comfort during short-term use. This design is particularly advantageous in acute settings where stability and quick deployment are critical.

• Can the Semi-Floating Pacing Kit be reused, and what are the storage requirements?

  No, the kit is explicitly designed for single-use only and should not be reused. Storage must adhere to manufacturer guidelines for sterile medical devices, typically in a clean, dry environment protected from moisture, extreme temperatures, and direct sunlight. Ensure the packaging remains intact until immediate use to preserve sterility.

• Does the Semi-Floating Pacing Kit have any special considerations for clinical environments, such as MRI safety?

  The device data does not specify MRI safety information, meaning its compatibility with MRI environments has not been evaluated or confirmed. Clinicians should avoid using this kit in MRI settings unless explicit manufacturer guidance or testing confirms its safety. Always verify compatibility with hospital MRI protocols before deployment.