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U.S. Department of Health and Human Services

Product Classification

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Device temporary catheter, embolic protection, transcatheter intracardiac procedures
Definition Embolic protection for transcatheter intracardiac procedures
Physical State This device is a single use percutaneous catheter system that has (a) blood filter(s) at the distal end and is introduced into an artery through the skin using a guidewire.
Technical Method This device is a single use percutaneous catheter system that is introduced into an artery.
Target Area Aortic arch or aortic arch branch vessels.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodePUM
Premarket Review Cardiovascular Devices (OHT2)
Circulatory Support, Structural and Vascular Devices (DHT2B)
Submission Type 510(k)
Regulation Number 870.1251
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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