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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Vascular, For Promoting Embolization
510(k) Number K250276
Device Name Nitinol Enhanced Device (NED)
Applicant
Embolization, Inc.
5421 Western Ave.
Boulder,  CO  80301
Applicant Contact James Kasic
Correspondent
Boulder Biomed, LLC, Dba Boulder IQ Dba Boulder
Sterilization
5421 Western Ave.
Boulder,  CO  80301
Correspondent Contact Melissa Brookshier
Regulation Number870.3300
Classification Product Code
KRD  
Date Received01/31/2025
Decision Date 05/15/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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