Aptus Heli-Fx Guide - 22CM Deflectable Length; Aptus Heli-Fx Guide - 28CM Deflectable Length; Aptus Heli-Fx Applier with

FDA 510(k) K140036 · Aptus Endosystems, Inc.

Substantially Equivalent

510(k) numberK140036

Submission

Device name
Aptus Heli-Fx Guide - 22CM Deflectable Length; Aptus Heli-Fx Guide - 28CM Deflectable Length; Aptus Heli-Fx Applier with
Applicant
Aptus Endosystems, Inc.
Sunnyvale, CA, US
Received
January 7, 2014
Decision date
February 6, 2014
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
OTD – Endovascular Suturing System
Device class
Class II (moderate risk)
Regulation
21 CFR 870.3460
Specialty
Cardiovascular
Implant
Yes

Provides fixation and sealing between and endovascular graft and the native artery.

Other 510(k)s with product code OTD

510(k)DeviceApplicantDecision
K182957Heli-FX EndoAnchor SystemOTD · Special Medtronic Vascular, Inc.11/21/2018SE
K171427Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor CassetteOTD · Special Medtronic Vascular, Inc.06/13/2017SE
K141041Aptus Heli-Fx Ancillary Endoanchor CassetteOTD · Special Aptus Endosystems05/16/2014SE
K130677Aptus Heli-Fx Aortic Securement SystemOTD · Special Aptus Endosystems, Inc.04/12/2013SE
K121168Aptus 18FR Helifx GUIDE-22 Deflectable LengthOTD · Traditional Aptus Endosystems, Inc.08/08/2012SE

More from Aptus Endosystems, Inc.

510(k)DeviceDecision
K141041Aptus Heli-Fx Ancillary Endoanchor CassetteOTD · Special 05/16/2014SE
K130677Aptus Heli-Fx Aortic Securement SystemOTD · Special 04/12/2013SE
K121168Aptus 18FR Helifx GUIDE-22 Deflectable LengthOTD · Traditional 08/08/2012SE

Questions and answers

When was Aptus Heli-Fx Guide - 22CM Deflectable Length; Aptus Heli-Fx Guide - 28CM Deflectable Length; Aptus Heli-Fx Applier with cleared by the FDA?

Aptus Heli-Fx Guide - 22CM Deflectable Length; Aptus Heli-Fx Guide - 28CM Deflectable Length; Aptus Heli-Fx Applier with (K140036) received a 510(k) decision of Substantially Equivalent on February 6, 2014, 30 days after the submission was received.

What is the product code of K140036?

The FDA product code is OTD – Endovascular Suturing System, a Class II (moderate risk) device regulated under 21 CFR 870.3460.