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U.S. Department of Health and Human Services

Product Classification

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Device catheter, flow directed
Regulation Description Flow-directed catheter.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeDYG
Premarket Review Office of Cardiovascular Devices (OHT2)
Coronary and Peripheral Interventional Devices (DHT2C)
Submission Type 510(k)
Regulation Number 870.1240
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons
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