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U.S. Department of Health and Human Services

Product Classification

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Device introducer, catheter
Regulation Description Catheter introducer.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeDYB
Premarket Review Cardiovascular Devices (OHT2)
Coronary and Peripheral Interventional Devices (DHT2C)
Submission Type 510(k)
Regulation Number 870.1340
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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