Cleared Traditional

K200198 - WIRION (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K200198 · Cardiovascular Systems, Inc. · Cardiovascular device
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Mar 2020
Decision
51d
Days
Class 2
Risk

K200198 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 Cardiovascular Systems, Inc. (St.Paul, US). The FDA issued a Cleared decision on March 18, 2020 after a review of 51 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 Cardiovascular Systems, Inc. devices

Submission Details

510(k) Number K200198 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2020
Decision Date March 18, 2020
Days to Decision 51 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 125d · This submission: 51d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.