Not Cleared Direct

DEN150029 - Permaseal (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN150029 · Micro Interventional Devices,Inc. · Cardiovascular device
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Jul 2016
Decision
401d
Days
Class 2
Risk

DEN150029 is an FDA 510(k) submission (not cleared) for the Permaseal. Classified as Apical Closure Device (product code PNQ), Class II - Special Controls.

Submitted by Micro Interventional Devices,Inc. (Newtown, US). The FDA issued a Not Cleared (DENG) decision on July 27, 2016 after a review of 401 days.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4510 - 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 401 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.

View all Micro Interventional Devices,Inc. devices

Submission Details

510(k) Number DEN150029 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received June 22, 2015
Decision Date July 27, 2016
Days to Decision 401 days
Submission Type Direct
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
276d slower than avg
Panel avg: 125d · This submission: 401d
Pathway characteristics

Device Classification

Product Code PNQ Apical Closure Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4510
Definition This Device Is Intended For Closure Of Cardiac Apical Tissue.
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.