Medical Device Manufacturer · US , Redwood City , CA

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

25 submissions · 25 cleared · Since 2009

Recent clearances: Pantheris LV Atherectomy Catheter, Tigereye ST CTO-Crossing Catheter, Tigereye CTO-Crossing Catheter

25
Total
25
Cleared
0
Denied

Avinger, Inc. has 25 FDA 510(k) cleared cardiovascular devices. Based in Redwood City, US.

Last cleared in 2023. Active since 2009.

Browse the complete list of FDA 510(k) cleared cardiovascular devices from this manufacturer. Filter by specialty or product code using the sidebar.

1 device has linked clinical trial registered on ClinicalTrials.gov.

FDA 510(k) Regulatory Record - Avinger, Inc.

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 CT 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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