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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 Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Interventional Cardiology Devices Branch (ICDB)
Submission Type 510(k)
Regulation Number 870.1210
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons