Medical Device Manufacturer · US , Redwood City , CA

Avinger, Inc.

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

Avinger, Inc. — FDA 510(k) Submissions

Avinger, Inc. has submitted 25 FDA 510(k) premarket notifications since 2009, of which 25 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Catheter For Crossing Total Occlusions, Catheter, Peripheral, Atherectomy, Catheter, Percutaneous . Use the specialty filter in the sidebar to narrow results.

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