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U.S. Department of Health and Human Services

Product Classification

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Device occluder, catheter tip
Regulation Description Catheter tip occluder.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeDQT
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Interventional Cardiology Devices Branch (ICDB)
Submission Type 510(k)
Regulation Number 870.1370
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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