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U.S. Department of Health and Human Services

Product Classification
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Device aspiration thrombectomy catheter
Regulation Description Embolectomy catheter.
Definition To remove thrombus from the peripheral and/or coronary vasculature through aspiration.
Physical State Peripheral and/or coronary catheter
Technical Method removed thrombus from the vasculature
Target Area Peripheral and/or coronary vasculature
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeQEZ
Premarket Review Coronary and Peripheral Interventional Devices (DHT2C)
Coronary and Peripheral Interventional Devices (DHT2C)
Submission Type 510(k)
Regulation Number 870.5150
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? Yes
    Note: This device is also exempted from the GMP regulation, except for general requirements concerning records (820.180) and complaint files (820.198), as long as the device is not labeled or otherwise represented as sterile.
Summary Malfunction
Reporting		 Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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