OTD · Class II · 21 CFR 870.3460

FDA Product Code OTD: Endovascular Suturing System

Provides Fixation And Sealing Between And Endovascular Graft And The Native Artery.

Leading manufacturers include Aptus Endosystems, Inc., Medtronic Vascular, Inc. and Aptus Endosystems.

7
Total
6
Cleared
85d
Avg days
2011
Since

FDA 510(k) Cleared Endovascular Suturing System Devices (Product Code OTD)

7 devices
1–7 of 7
Cleared Nov 21, 2018
Heli-FX EndoAnchor System
K182957
Medtronic Vascular, Inc.
Cardiovascular · 28d
Cleared Jun 13, 2017
Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor Cassette
K171427
Medtronic Vascular, Inc.
Cardiovascular · 29d
Cleared May 16, 2014
APTUS HELI-FX ANCILLARY ENDOANCHOR CASSETTE
K141041
Aptus Endosystems
Cardiovascular · 23d
Cleared Feb 06, 2014
APTUS HELI-FX GUIDE - 22CM DEFLECTABLE LENGTH
K140036
Aptus Endosystems, Inc.
Cardiovascular · 30d
Cleared Apr 12, 2013
APTUS HELI-FX AORTIC SECUREMENT SYSTEM
K130677
Aptus Endosystems, Inc.
Cardiovascular · 30d
Cleared Aug 08, 2012
APTUS 18FR HELIFX GUIDE-22 DEFLECTABLE LENGTH
K121168
Aptus Endosystems, Inc.
Cardiovascular · 113d
Not Cleared Nov 21, 2011
APTUS STEERABLE ENDOGUIDE WITH OBTURATOR, APTUS ENDOSTAPLE APPLIER WITH ENDOSTAPLE CASSETTE, APTUS ENDOSTAPLE CASSETTE
DEN100026
Aptus Endosystems, Inc.
Cardiovascular · 342d

About Product Code OTD - Regulatory Context