Cleared Traditional

K081523 - EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM (FDA 510(k) Clearance)

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

K081523 · Abbott Vascular-Vascular Solutions · Cardiovascular device
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Sep 2008
Decision
101d
Days
Class 2
Risk

K081523 is an FDA 510(k) clearance for the EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM. Classified as Temporary Carotid Catheter For Embolic Capture (product code NTE), Class II - Special Controls.

Submitted by Abbott Vascular-Vascular Solutions (Santa Clara, US). The FDA issued a Cleared decision on September 11, 2008 after a review of 101 days - within the typical 510(k) review window.

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.

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Submission Details

510(k) Number K081523 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2008
Decision Date September 11, 2008
Days to Decision 101 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
24d faster than avg
Panel avg: 125d · This submission: 101d
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.