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U.S. Department of Health and Human Services

Product Classification

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Device agents, embolic, for treatment of uterine fibroids
Regulation Description Vascular embolization device.
Regulation Medical Specialty Cardiovascular
Review Panel Obstetrics/Gynecology
Product CodeNAJ
Premarket Review Reproductive, Gynecology and Urology Devices (DHT3B)
Reproductive, Gynecology and Urology Devices (DHT3B)
Submission Type 510(k)
Regulation Number 870.3300
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Guidance Document
Third Party Review Not Third Party Eligible
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