Medical Device Manufacturer · US , Redwood City , CA

Avinger, Inc. - FDA 510(k) Cleared Devices

25 submissions · 25 cleared · Since 2009
25
Total
25
Cleared
0
Denied

FDA 510(k) cleared devices by Avinger, Inc. Cardiovascular

25 devices
1-25 of 25
Cleared Jun 06, 2023
Pantheris LV Atherectomy Catheter
K230005 · MCW
Cardiovascular · 154d
Cleared Apr 25, 2023
Tigereye ST CTO-Crossing Catheter
K230594 · PDU
Cardiovascular · 53d
Cleared Jan 06, 2022
Tigereye CTO-Crossing Catheter
K212468 · PDU
Cardiovascular · 153d
Cleared Nov 16, 2021
Pantheris System
K212047 · MCW
Cardiovascular · 139d
Cleared Sep 10, 2020
Tigereye CTO-Crossing Catheter
K201330 · PDU
Cardiovascular · 114d
Cleared Apr 09, 2019
Pantheris SV
K182341 · MCW
Cardiovascular · 224d
Cleared May 22, 2018
Pantheris System
K173862 · MCW
Cardiovascular · 153d
Cleared Oct 30, 2017
Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging...
K172236 · MCW
Cardiovascular · 97d
Cleared Dec 21, 2016
Pantheris Catheter (8F)
K163264 · MCW
Cardiovascular · 30d
Cleared Oct 18, 2016
Pantheris Catheter, Lightbix HS Imaging Console, Lightbox Sled
K162326 · MCW
Cardiovascular · 60d
Cleared Apr 21, 2016
Pantheris Catheter
K160827 · MCW
Cardiovascular · 27d
Cleared Mar 01, 2016
Pantheris Catheter (8Fr), Pantheris Catheter (7Fr)
K153460 · MCW
Cardiovascular · 91d
Cleared Oct 14, 2015
Pantheris System
K152275 · MCW
Cardiovascular · 63d
Cleared May 01, 2014
OCELOT CATHETER, OCELOT PIXL CATHETER, LIGHTBOX CONSOLE
K140185 · PDU
Cardiovascular · 97d
Cleared Dec 14, 2012
OCELOT PIXL CATHETER
K123532 · PDU
Cardiovascular · 28d
Cleared Dec 07, 2012
OCELOT CATHETER
K123462 · PDU
Cardiovascular · 28d
Cleared Nov 07, 2012
OCELOT SYSTEM
K122380 · PDU
Cardiovascular · 93d
Cleared Mar 30, 2012
KITTYCAT CATHETER, KITTYCAT 2 CATHETER
K120273 · PDU
Cardiovascular · 60d
Cleared Mar 12, 2012
WILDCAT CATHETER
K113838 · PDU
Cardiovascular · 75d
Cleared Oct 06, 2011
WILDCAT 5F GUIDEWIRE SUPPORT CATHETER
K112579 · DQY
Cardiovascular · 30d
Cleared Sep 09, 2011
AVINGER WILDCAT 6F GUIDEWIRE SUPPORT CATHETER AND JUICEBOX
K111704 · DQY
Cardiovascular · 84d
Cleared Aug 11, 2011
WILDCAT CATHETER
K111338 · PDU
Cardiovascular · 91d
Cleared Aug 06, 2010
WILDCAT 5F GUIDEWIRE SUPPORT CATHETER, MODE W500
K101647 · DQY
Cardiovascular · 56d
Cleared Aug 06, 2010
WILDCAT 6F GUIDEWIRE SUPPORT CATHETER MODEL W400L AND W400S
K102022 · DQY
Cardiovascular · 18d
Cleared Feb 02, 2009
WILDCAT 7F GUIDEWIRE SUPPORT CATHETER
K083313 · DQY
Cardiovascular · 84d
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