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510(k) K261715

Emboliner Embolic Protection System (EPC-03) by Emboline, Inc. — Product Code PUM

K261715 is an FDA 510(k) premarket notification submitted by Emboline, Inc. for the device "Emboliner Embolic Protection System (EPC-03)". The FDA issued a decision of Substantially Equivalent on Sep 8, 2026. The device falls under product code PUM (Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures), a Class II device regulated under 21 CFR 870.1251.

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: Sep 8, 2026
Date Received: May 22, 2026
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures
Device Class: Class II
Regulation Number: 870.1251
Review Panel: CV
Submission Type

Embolic protection for transcatheter intracardiac procedures