Cleared Traditional

K222694 - EmPro EPS (EP4514C-190, EP6514C-190) (FDA 510(k) Clearance)

Also includes:
Nanoparasol EPS (PNP4514C-190,PNP6514C-190)

Class II Cardiovascular device cleared through predicate-based substantial equivalence.

K222694 · MicroVention, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2023
Decision
233d
Days
Class 2
Risk

K222694 is an FDA 510(k) clearance for the EmPro EPS (EP4514C-190, EP6514C-190). Classified as Temporary Carotid Catheter For Embolic Capture (product code NTE), Class II - Special Controls.

Submitted by MicroVention, Inc. (Aliso Viejo, US). The FDA issued a Cleared decision on April 27, 2023 after a review of 233 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - 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 MicroVention, Inc. devices

Submission Details

510(k) Number K222694 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 2022
Decision Date April 27, 2023
Days to Decision 233 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
108d slower than avg
Panel avg: 125d · This submission: 233d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code NTE Temporary Carotid Catheter For Embolic Capture
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
Definition This Device Is A Single Use Percutaneous Catheter System That Is Introduced Into An Artery Through The Skin Using A Guidewire. The Catheter Has An Embolic Capture Filter Or An Occlusion Balloon At The Distal End. The Filter Or Balloon Can Be Placed Either Distally To The Lesion Or Proximally Depending On The Design Of The Device And Intended Use. The Filter Or Balloon Is Used To Capture Embolic Material In A Manner That May Protect Or Prevent A Stroke Or Other Cerebral Vascular Sequelae. The Embolic Capture Device Is Indicated For Use As A Guidewire And Embolic Protection System To Contain And Remove Embolic Material (thrombus/debris) While Performing Angioplasty And Stenting Procedures I
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
NCT02657707 Unknown Interventional Industry-sponsored

Evaluation of the Roadsaver Stent Used in Conjunction With the Nanoparasol Embolic Protection System for Carotid Artery Stenosis

Pivotal Study of the MicroVention, Inc. Carotid Artery Stent System Used in Conjunction With the Nanoparasol® Embolic Protection System for the Treatment of Carotid Artery Stenosis in Patients at Elevated Risk for Adverse Events From Carotid Endarterectomy.(CONFIDENCE Trial)

295
Patients (est.)
37
Sites
Treatment
Purpose
Open label
Masking
Condition studied Carotid Artery Stenosis
Study design Single group
Eligibility All sexes · 21 Years+
Principal investigator Adnan Siddiqui, MD
Sponsor Microvention-Terumo, Inc. (industry)
Started 2016-04-21 → Primary completion 2022-04-08 → Completed 2024-05-01
Primary outcome
All stroke, death, and MI
Secondary outcome
Successful deployment of stent
View full study on ClinicalTrials.gov