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U.S. Department of Health and Human Services

Product Classification

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Device device, vascular, for promoting embolization
Regulation Description Vascular embolization device.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeKRD
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Vascular Surgery Devices Branch (VSDB)
Submission Type 510(k)
Regulation Number 870.3300
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • Vascular and Neurovascular Embolization Devices - Class II Special Controls Guidance Document - Guidance for Industry and FDA Staff
Third Party Review Not Third Party Eligible
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