MobiCath Transseptal Needle

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

510(k) Number

K122832 ↗

FDA Product Code

DRC

Device Class

Class II

Regulation

21 CFR Part 870.1390

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K112541 Active Cleared 7 Feb 2012

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• Mobicath Transseptal Needle

  Class II

  FDA 510(k) K111644 Active Cleared 3 Oct 2011

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• What is the MobiCath Transseptal Needle used for?

  The MobiCath Transseptal Needle is designed specifically for creating punctures in the inter-atrial septum during cardiovascular procedures. Its curved distal tip and thin-walled stainless steel cannula allow for precise transseptal access, facilitating interventions such as cardiac ablation, device implantation (e.g., pacemakers or defibrillators), or diagnostic sampling across the atrial septum. This targeted access is critical for procedures requiring crossing from the right to the left atrium.

• How is the MobiCath Transseptal Needle supplied and what are its key features?

  The device is supplied as a single-use, sterile instrument, ensuring patient safety and reducing cross-contamination risks. It includes an ergonomic handle with an integrated pointer for orientation, aiding clinicians in accurate needle placement. The handle also features a two-way stopcock, enabling functions like air aspiration, fluid infusion, blood sampling, and pressure monitoring—essential for real-time procedural adjustments. The needle is paired with an over-molded stylet hub for added stability during use.

• Is the MobiCath Transseptal Needle reusable or intended for single-use?

  The MobiCath Transseptal Needle is explicitly designed for single-use only. This classification aligns with FDA regulations for Class II medical devices and ensures compliance with infection control protocols. Single-use devices minimize the risk of contamination between patients, which is particularly important in sterile cardiovascular procedures where precision and sterility are paramount.

• Are there different sizes or models available for the MobiCath Transseptal Needle?

  The provided regulatory data does not specify multiple sizes or distinct models for the MobiCath Transseptal Needle. However, the device’s curved distal tip and ergonomic handle are tailored for transseptal access, suggesting it is engineered to meet standard procedural requirements. If specific sizing is required for a patient or procedure, consultation with the manufacturer or clinical guidelines would be necessary to confirm compatibility.

• What storage conditions should be followed for the MobiCath Transseptal Needle?

  The regulatory documentation for the MobiCath Transseptal Needle does not detail explicit storage conditions. As a sterile, single-use device, it should be stored in a clean, dry environment protected from physical damage, extreme temperatures, or direct sunlight. If the packaging is damaged or compromised, the device should not be used. For optimal shelf life and sterility, adhering to standard medical device storage protocols—such as those outlined by the manufacturer—is recommended.