Cleared Traditional

K180023 - WIRION

K180023 is the FDA 510(k) clearance for WIRION by Gardia Medical , Ltd.. It is a Class 2 Cardiovascular device (product code NTE) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K180023 · Gardia Medical , Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2018
Decision
77d
Days
Class 2
Risk

K180023 is an FDA 510(k) clearance for the WIRION. Classified as Temporary Carotid Catheter For Embolic Capture (product code NTE), Class II - Special Controls.

Submitted by Gardia Medical , Ltd. (Caesarea, IL). The FDA issued a Cleared decision on March 21, 2018 after a review of 77 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Gardia Medical , Ltd. devices

Submission Details

510(k) Number K180023 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 2018
Decision Date March 21, 2018
Days to Decision 77 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
48d faster than avg
Panel avg: 125d · This submission: 77d
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
NCT01042444 Terminated Interventional Industry-sponsored

Use of the GARDEX™ Embolic Protection Device During Percutaneous Coronary Interventions of Saphenous Vein Graft

Phase I Study to Demonstrate the Safety and Performance of the GARDEX™ Embolic Protection Device When Used During Percutaneous Coronary Intervention (PCI) of Saphenous Vein Graft

6
Patients (actual)
3
Sites
Treatment
Purpose
Open label
Masking
Condition studied Saphenous Vein Graft Disease; Myocardial Ischemia; Embolism
Study design Single group
Eligibility All sexes · 18 Years+
Principal investigator Uri Rosenschein, MD
Sponsor Gardia Medical (industry)
Started 2009-12-01 → Primary completion 2011-01-01
Primary outcome
The primary objective of the study is to evaluate the safety and performance of the GARDEX Protection System. The primary end point is the combined rate of major adverse events (MACE) at 30 days.
Secondary outcome
The secondary study objectives includes Device,Angiographic,Procedural and Clinical Success ,Final TIMI flow grade, Angiographically evident emboli
View full study on ClinicalTrials.gov

Regulatory Peers - NTE Temporary Carotid Catheter For Embolic Capture

All 19
Devices cleared under the same product code (NTE) and FDA review panel - the closest regulatory comparables to K180023.
WIRION Embolic Protection System
K210282 · Cardiovascular Systems, Inc. · Mar 2021
WIRION
K200198 · Cardiovascular Systems, Inc. · Mar 2020
Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery Wires
K191173 · Abbott Vascular · Jul 2019
GORE FLOW REVERSAL SYSTEM MODEL GFRS073
K123156 · W.L. Gore & Associates, Inc. · Dec 2012
SPIDERFX EMBOLIC PROTECTION DEVICE
K111010 · Ev3, Inc. · Oct 2011
GORE EMBOLIC FILTER
K103500 · W.L. Gore & Associates, Inc. · May 2011