Emboliner Embolic Protection System (EPC-03)— 510(k) K261715

Name: FDA 510(k) clearance K261715
Creator: U.S. Food and Drug Administration
Published: 2026-09-08

Substantially Equivalent

Emboline, Inc.

FDA 510(k) clearance K261715 for Emboliner Embolic Protection System (EPC-03), Substantially Equivalent on 2026-09-08. Applicant: Emboline, Inc.. Device class: 2.

Clearance details

Applicant: Emboline, Inc.
Product code: Code PUM
Device class: Class 2
Regulation: 21 CFR 870.1251
Advisory panel: Cardiovascular
Date received: 2026-05-22
Decision date: 2026-09-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Cruz, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code PUM

product code PUM

Death: 3
Total: 3

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.