Cleared Special

K141041 - APTUS HELI-FX ANCILLARY ENDOANCHOR CASSETTE

K141041 is an FDA 510(k) clearance for APTUS HELI-FX ANCILLARY ENDOANCHOR CASSETTE, manufactured by Aptus Endosystems. The device is a Class 2 Cardiovascular device with product code OTD cleared through the Special 510(k) pathway after a 23-day FDA review.

K141041 · Aptus Endosystems · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2014
Decision
23d
Days
Class 2
Risk

K141041 is an FDA 510(k) clearance for the APTUS HELI-FX ANCILLARY ENDOANCHOR CASSETTE. Classified as Endovascular Suturing System (product code OTD), Class II - Special Controls.

Submitted by Aptus Endosystems (Sunnyvale, US). The FDA issued a Cleared decision on May 16, 2014 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3460 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K141041

510(k) Number K141041 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 2014
Decision Date May 16, 2014
Days to Decision 23 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 125d · This submission: 23d
Pathway characteristics
Modification to existing cleared device.

OTD Device Classification - Class 2, Special Controls

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.

Regulatory Peers - OTD Endovascular Suturing System

Devices cleared under the same product code (OTD) and FDA review panel - the closest regulatory comparables to K141041.
Heli-FX EndoAnchor System
K182957 · Medtronic Vascular, Inc. · Nov 2018
Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor Cassette
K171427 · Medtronic Vascular, Inc. · Jun 2017
APTUS HELI-FX GUIDE - 22CM DEFLECTABLE LENGTH
K140036 · Aptus Endosystems, Inc. · Feb 2014
APTUS HELI-FX AORTIC SECUREMENT SYSTEM
K130677 · Aptus Endosystems, Inc. · Apr 2013
APTUS 18FR HELIFX GUIDE-22 DEFLECTABLE LENGTH
K121168 · Aptus Endosystems, Inc. · Aug 2012
APTUS STEERABLE ENDOGUIDE WITH OBTURATOR, APTUS ENDOSTAPLE APPLIER WITH ENDOSTAPLE CASSETTE, APTUS ENDOSTAPLE CASSETTE
DEN100026 · Aptus Endosystems, Inc. · Nov 2011
K141041 · APTUS HELI-FX ANCILLARY ENDOANCHOR CASSETTE
Download PDF FDA Summary Aptus Endosystems