Cleared Traditional

EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190)

K222694 · MicroVention, Inc. · Cardiovascular

Apr 2023

Decision

233d

Days

Class 2

Risk

About This 510(k) Submission

K222694 is an FDA 510(k) clearance for the EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190), a Temporary Carotid Catheter For Embolic Capture (Class II — Special Controls, product code NTE), submitted by MicroVention, Inc. (Aliso Veijo, US). The FDA issued a Cleared decision on April 27, 2023, 233 days after receiving the submission on September 6, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number	K222694 FDA.gov
FDA Decision	Cleared 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

Device Classification

Product Code	NTE — Temporary Carotid Catheter For Embolic Capture
Device Class	Class II — 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