Disposable Temporary Pacing Wire

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

510(k) Number

K023174 ↗

FDA Product Code

LDF

Device Class

Class II

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• PTFE Piston

  Class II

  FDA 510(k) K913285 Active Cleared 18 Dec 1991

• River Pump

  Class II

  FDA 510(k) K932895 Active Cleared 31 Mar 1994

• Smartdose IV Prefilled Infusion Container

  Class II

  FDA 510(k) K944351 Active Cleared 15 Nov 1995

• Smartdose III Infusion Container

  Class II

  FDA 510(k) K944352 Active Cleared 15 Nov 1995

• H/A Partial - Regular & H/a Partial - Offset

  Class II

  FDA 510(k) K913287 Active Cleared 18 Dec 1991

• Collar Button Style Venturi

  Class II

  FDA 510(k) K904594 Active Cleared 28 Jan 1991

See all devices from River Medical, Inc. →

• What is the River Medical Temporary Pacing Wire used for?

  The River Medical Temporary Pacing Wire is designed for short-term cardiac pacing and sensing during and immediately after cardiac surgical procedures. It provides electrical stimulation to regulate heart rhythm when the heart’s natural conduction system is temporarily compromised, ensuring stable atrial and ventricular support.

• Is the Temporary Pacing Wire reusable or single-use?

  The device is explicitly supplied as a single-use item. This ensures sterility and reduces the risk of infection or cross-contamination between patients, aligning with best practices for temporary pacing applications.

• What distinguishes the dual-needle design of this pacing wire?

  The dual-needle design allows for precise and secure placement of the pacing wire within the heart chambers. This enhances accuracy during insertion, particularly for atrial and ventricular pacing, ensuring effective electrical stimulation while minimizing trauma to cardiac tissue.

• How should the Temporary Pacing Wire be stored?

  While storage conditions are not detailed in the regulatory submission, single-use medical devices like this are typically stored in a clean, dry environment protected from direct sunlight, extreme temperatures, and physical damage. Always follow manufacturer guidelines if additional instructions are provided.

• What regulatory pathway was used for FDA clearance of this device?

  The River Medical Temporary Pacing Wire received FDA 510(k) clearance through the Traditional pathway, demonstrating that it is substantially equivalent to a legally marketed predicate device. This classification falls under product code LDF, indicating its use in cardiovascular applications.