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U.S. Department of Health and Human Services

Product Classification

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Device catheter, continuous flush
Regulation Description Continuous flush catheter.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeKRA
Premarket Review Office of Cardiovascular Devices (OHT2)
Coronary and Peripheral Interventional Devices (DHT2C)
Submission Type 510(k)
Regulation Number 870.1210
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
Recognized Consensus Standard
Guidance Document
Third Party Review
Accredited Persons
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