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U.S. Department of Health and Human Services

Product Classification

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Device filter, intravascular, cardiovascular
Regulation Description Cardiovascular intravascular filter.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeDTK
Premarket Review Cardiovascular Devices (OHT2)
Coronary and Peripheral Intervention Devices (DHT2C)
Submission Type 510(k)
Regulation Number 870.3375
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Recognized Consensus Standards
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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