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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures
510(k) Number K261715
Device Name Emboliner Embolic Protection System (EPC-03)
Applicant
Emboline, Inc.
2901 Mission St.
Bldg. 2
Santa Cruz,  CA  95060
Applicant Contact Will Michul
Correspondent
Emboline, Inc.
2901 Mission St.
Bldg. 2
Santa Cruz,  CA  95060
Correspondent Contact Will Michul
Regulation Number870.1251
Classification Product Code
PUM  
Date Received05/22/2026
Decision Date 09/08/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Clinical Trials NCT05684146
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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