Biflex Temporary Pacing Probe

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

Full name

Biflex Tm Temporary Pacing Probe

510(k) Number

K790983 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Athans Ekg Standardizer

  Class II

  FDA 510(k) K903671 Active Cleared 3 Jan 1991

• Teves Ecm Plus Thermocouple

  Class II

  FDA 510(k) K951768 Active Cleared 15 Dec 1995

• What clinical scenarios is the Biflex Temporary Pacing Probe designed to address, and how does it differ from permanent pacing electrodes?

  The Biflex Temporary Pacing Probe is specifically designed for acute cardiac pacing applications, such as managing arrhythmias or heart block in patients who require temporary support until a more permanent solution can be implemented. Unlike permanent pacemaker electrodes, it is intended for short-term use in critical settings where immediate cardiac rhythm stabilization is needed. Its flexible, insulated conductors and single-use design make it ideal for temporary pacing systems, ensuring reliability during transient clinical needs.

• Is the Biflex Temporary Pacing Probe reusable, or is it meant for single-use only? What does this mean for clinical workflow?

  The Biflex Temporary Pacing Probe is explicitly designed for single-use only, supplied sterile and packaged for immediate clinical application. This eliminates the need for sterilization between patients, streamlining workflows in acute care settings where time and sterility are critical. Clinicians can open the sterile packaging and use it directly without additional preparation, reducing the risk of contamination and ensuring patient safety.

• What sizes or models of the Biflex Temporary Pacing Probe are available, and how do they differ?

  The provided data lists multiple FEI numbers (e.g., 3002618605, 1028232, etc.) associated with the Biflex Temporary Pacing Probe, which likely correspond to different electrode configurations, lengths, or lead types (e.g., atrial, ventricular, or biventricular pacing). While exact specifications aren’t detailed here, these variations allow clinicians to select the appropriate probe based on patient anatomy, pacing requirements, or procedural needs. For precise sizing or model selection, refer to the manufacturer’s catalog or technical documentation.

• How should the Biflex Temporary Pacing Probe be stored, and what precautions should be taken to maintain its sterility?

  The probe is supplied sterile and packaged for immediate clinical use, meaning it should remain in its original, unopened packaging until ready for deployment. Storage should be in a clean, dry environment protected from extreme temperatures, moisture, or physical damage. Once opened, it must be used immediately—never stored for later use—to preserve sterility and prevent contamination. Avoid exposing the packaging to direct sunlight or chemical fumes, as these could compromise the probe’s integrity.

• What temporary pacing systems is the Biflex Temporary Pacing Probe compatible with, and does it require any special preparation before use?

  The Biflex Temporary Pacing Probe is compatible with standard temporary pacing systems commonly used in acute care, such as external pacemakers or transvenous pacing leads. No additional sterilization is required beyond its original packaging, as it is pre-sterilized for single-use. Before use, clinicians should verify compatibility with their specific pacing system (e.g., impedance matching, connector type) and follow manufacturer guidelines for proper insertion and electrical connection to ensure safe and effective pacing.