Not Cleared Post-NSE

DEN080015 - NUCLEUS-X PTV CATHETER

DEN080015 is the FDA 510(k) submission for NUCLEUS-X PTV CATHETER by NuMED, Inc.. It is a Class 2 Cardiovascular device (product code OZT) cleared through the Post-NSE 510(k) pathway after a 1265-day FDA review.

DEN080015 · NuMED, Inc. · Cardiovascular device
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Jun 2012
Decision
1265d
Days
Class 2
Risk

DEN080015 is an FDA 510(k) submission (not cleared) for the NUCLEUS-X PTV CATHETER. Classified as Balloon Aortic Valvuloplasty (product code OZT), Class II - Special Controls.

Submitted by NuMED, Inc. (Hopkinton, US). The FDA issued a Not Cleared (DENG) decision on June 11, 2012 after a review of 1265 days.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1255 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 1265 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

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Submission Details

510(k) Number DEN080015 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received December 24, 2008
Decision Date June 11, 2012
Days to Decision 1265 days
Submission Type Post-NSE
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1140d slower than avg
Panel avg: 125d · This submission: 1265d
Pathway characteristics

Device Classification

Product Code OZT Balloon Aortic Valvuloplasty
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1255
Definition A Balloon Aortic Valvuloplasty Catheter Is Indicated For Balloon Valvuloplasty Of The Aortic Valve.
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.