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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, intravascular, diagnostic
510(k) Number K232536
Device Name Soldier Microcatheter
Applicant
Embolx, Inc.
530 Lakeside Dr. Suite 200
Sunnyvale,  CA  94085
Applicant Contact Louise Musante
Correspondent
Embolx, Inc.
530 Lakeside Dr. Suite 200
Sunnyvale,  CA  94085
Correspondent Contact Louise Musante
Regulation Number870.1200
Classification Product Code
DQO  
Date Received08/21/2023
Decision Date 02/23/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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