StimuCath Continuous Nerve Block Set, Models AB-02030, AB-02060, AB-02090, AB-02030-PK, AB-02060-PK, AB-02090-PK

• • Terminated Z-2894-2011 FDA Unclassified (pre-2012) ·initiated 17 Jun 2011

  Some of the outer trays used in the packaging were found to have an insufficient seal. Therefore, packaging may have been compromised, and sterility of the product cannot be guaranteed.

510(k) Number

K030937 ↗

FDA Product Code

CAZ

Models / Variants

Ab-02030

Ab-02060

Ab-02090

Ab-02030-Pk

Ab-02060-Pk

Ab-02090-Pk

Device Class

Class II

Regulation

21 CFR Part 868.5140

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

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See all devices from Arrow International, Inc. →

• What is the StimuCath Continuous Nerve Block Set used for?

  The StimuCath Continuous Nerve Block Set is designed for peripheral nerve block procedures, enabling clinicians to deliver continuous anesthesia or analgesia for up to 72 hours. It is particularly useful in operating rooms or procedural suites where targeted nerve or plexus localization is required. The electrically conductive catheter allows for nerve stimulation to confirm accurate catheter placement, ensuring effective and prolonged pain management or surgical anesthesia.

• How are the different models of the StimuCath kit distinguished?

  The models of the StimuCath Continuous Nerve Block Set are differentiated by catheter length and packaging type. Models AB-02030, AB-02060, and AB-02090 correspond to varying catheter lengths, while the -PK variants (e.g., AB-02030-PK) indicate a specific packaging configuration. This allows clinicians to select the appropriate length and packaging for their procedural needs.

• Is the StimuCath kit sterile and single-use?

  Yes, the StimuCath Continuous Nerve Block Set is supplied sterile and is intended for single-use only. This ensures patient safety by preventing cross-contamination and maintaining device integrity for optimal performance during procedures.

• Can this device be reused?

  No, the StimuCath Continuous Nerve Block Set is explicitly designed for single-use. Reusing the device could compromise sterility, catheter integrity, or nerve stimulation accuracy, potentially leading to adverse clinical outcomes. Always adhere to the manufacturer’s instructions for proper disposal after a single use.

• What storage conditions are recommended for the StimuCath kit?

  While specific storage instructions are not detailed in the provided data, sterile medical devices like the StimuCath kit typically require protection from physical damage, extreme temperatures, and contamination. Store in a clean, dry environment, away from direct sunlight or moisture, and follow the manufacturer’s guidelines for shelf-life and expiration dates to ensure device efficacy and sterility.