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FDA 510(k)

Emboliner Embolic Protection System (EPC-03)

K-Number: K261715 · 2026-09-08

ApplicantEmboline, Inc.
Decision Date2026-09-08
Product CodePUM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Emboliner Embolic Protection System (EPC-03) is the device name listed in this FDA 510(k) record. The listed applicant is Emboline, Inc.. It received FDA 510(k) clearance on 2026-09-08 under 510(k) number K261715. The device is classified under product code PUM. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Emboliner Embolic Protection System (EPC-03)?

Emboliner Embolic Protection System (EPC-03) is a medical device that received FDA 510(k) clearance on 2026-09-08. The listed applicant is Emboline, Inc.. The 510(k) number is K261715.

When did Emboliner Embolic Protection System (EPC-03) receive FDA 510(k) clearance?

Emboliner Embolic Protection System (EPC-03) received FDA 510(k) clearance on 2026-09-08, under 510(k) number K261715.

Who is the listed applicant for Emboliner Embolic Protection System (EPC-03)?

The FDA 510(k) record lists Emboline, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Emboliner Embolic Protection System (EPC-03)?

The FDA product code for Emboliner Embolic Protection System (EPC-03) is PUM.

Related Devices (Code: PUM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K192460Sentinel Cerebral Protection SystemBoston Scientific Corporation

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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