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U.S. Department of Health and Human Services

Product Classification

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Device short-term intravascular filter catheter
Regulation Description Cardiovascular intravascular filter.
Definition For short-term prevention of pulmonary embolism (PE)
Physical State Filter attached to a catheter
Technical Method Mechanically filters the bloodstream to capture blood clots
Target Area Peripheral vasculature (vein), inferior vena cava (IVC)
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodePNS
Premarket Review Cardiovascular Devices (OHT2)
Coronary and Peripheral Interventional 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
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible