FDA-Device2024-07-03Class II
The D*Clot¿ HD Rotational Thrombectomy System is a percutaneous catheter-based system available in 6 French. The disposable system consists of an outer sheath through which a rotatable radiopaque spiral shaft extends ending in an eccentric blunt distal tip. Once activated, the shaft rotates at approximately 10.000 RPMs to break thrombus into smaller particles, which can be simultaneously aspirated using a dedicated vacuum syringe. The catheter is a stand-alone system and is powered by a 4.5 VDC
Mermaid Medical A/S
Hazard
Internal product testing failed bubble leak testing (ASTM F2096), which indicates the sterility barrier may not be fully intact.
Sold states
Worldwide - US Nationwide distribution in the states of OH, MO, CO, NC, TX, MA, GA, FL, IL, IN, MD, PA, VA, and the country of Chile.
Affected count
190 devices
Manufactured in
Frydensbergvej 25, Stenlose, Denmark
Products
The D*Clot¿ HD Rotational Thrombectomy System is a percutaneous catheter-based system available in 6 French. The disposable system consists of an outer sheath through which a rotatable radiopaque spiral shaft extends ending in an eccentric blunt distal tip. Once activated, the shaft rotates at approximately 10.000 RPMs to break thrombus into smaller particles, which can be simultaneously aspirated using a dedicated vacuum syringe. The catheter is a stand-alone system and is powered by a 4.5 VDC alkaline battery pack in the control unit.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2213-2024Don't want to check this manually?
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