Not Cleared Post-NSE

DEN100026 - APTUS STEERABLE ENDOGUIDE WITH OBTURATOR, APTUS ENDOSTAPLE APPLIER WITH ENDOSTAPLE CASSETTE, APTUS ENDOSTAPLE CASSETTE (FDA 510(k) Clearance)

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

DEN100026 · Aptus Endosystems, Inc. · Cardiovascular device
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Nov 2011
Decision
342d
Days
Class 2
Risk

DEN100026 is an FDA 510(k) submission (not cleared) for the APTUS STEERABLE ENDOGUIDE WITH OBTURATOR, APTUS ENDOSTAPLE APPLIER WITH ENDOS.... Classified as Endovascular Suturing System (product code OTD), Class II - Special Controls.

Submitted by Aptus Endosystems, Inc. (Sunnyvale, US). The FDA issued a Not Cleared (DENG) decision on November 21, 2011 after a review of 342 days.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3460 - 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 342 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 Aptus Endosystems, Inc. devices

Submission Details

510(k) Number DEN100026 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received December 14, 2010
Decision Date November 21, 2011
Days to Decision 342 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
217d slower than avg
Panel avg: 125d · This submission: 342d
Pathway characteristics

Device Classification

Product Code OTD Endovascular Suturing System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3460
Definition Provides Fixation And Sealing Between And Endovascular Graft And The Native Artery.
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.