Cleared Traditional

K261715 - Emboliner Embolic Protection System (EPC-03)

K261715 is an FDA 510(k) clearance for Emboliner Embolic Protection System (EP..., manufactured by Emboline, Inc.. The device is a Class 2 Cardiovascular device with product code PUM cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K261715 · Emboline, Inc. · Cardiovascular device
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Sep 2026
Decision
109d
Days
Class 2
Risk

K261715 is an FDA 510(k) clearance for the Emboliner Embolic Protection System (EPC-03). Classified as Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures (product code PUM), Class II - Special Controls.

Submitted by Emboline, Inc. (Santa Cruz, US). The FDA issued a Cleared decision on September 8, 2026 after a review of 109 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1251 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Emboline, Inc. devices

FDA 510(k) Submission Details - K261715

510(k) Number K261715 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 2026
Decision Date September 08, 2026
Days to Decision 109 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 125d · This submission: 109d
Pathway characteristics
Predicate-based equivalence.

PUM Device Classification - Class 2, Special Controls

Product Code PUM Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1251
Definition Embolic Protection For Transcatheter Intracardiac Procedures
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Cardiovascular devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT05684146 Unknown Interventional Industry-sponsored

Protect the Head to Head Study

Protect the Head to Head: A Safety and Efficacy Assessment of the Emboliner Embolic Protection Device

540
Patients (est.)
2
Sites
Treatment
Purpose
Open label
Masking
Condition studied Embolism
Study design Parallel
Eligibility All sexes · 18 Years+
Principal investigator Laura A Brenton
Sponsor Emboline (industry)
Started 2023-05-04 → Primary completion 2024-10-01 → Completed 2024-12-01
Primary outcome
Non-inferiority
Secondary outcome
Non-inferiority VARC-2
View full study on ClinicalTrials.gov