Avinger Inc

FDA Filings

This page includes the latest FDA filings for Avinger Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

USANASDAQAVGRDUNS 003152968
FDA Registration(s)
Registration Number3007498664
FEI Number3007498664
NameAVINGER, INC.
Owner & OperatorAvinger, Inc.
Contact Address400 Chesapeake Dr
Redwood City CA 94063 US
Official Correspondent
  • Thomas Lawson
  • x-510-2061794-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address400 Chesapeake Drive
Redwood City, CA 94063 US
Establishment Type
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device
  • Complaint File Establishment per 21 CFR 820.198



FDA Filings

Device
Company
DeviceDate
Avinger, Inc.
Tigereye CTO-Crossing Catheter2020-09-10
AVINGER, INC.
Pantheris SV A140-SV2019-08-12
AVINGER, INC.
Pantheris SV system2019-07-22
AVINGER, INC.
Pantheris SV system2019-07-22
Avinger, Inc.
Pantheris SV2019-04-09
AVINGER, INC.
Pantheris A400X2019-03-29
AVINGER, INC.
Pantheris A4002019-03-29
AVINGER, INC.
Lightbox Umbilical U2502019-03-29
AVINGER, INC.
CO2 C1002019-03-29
AVINGER, INC.
Sterile Drape SD1002019-03-29
AVINGER, INC.
Ocelot IV O2502019-03-29
AVINGER, INC.
Ocelot III O2002019-03-29
AVINGER, INC.
Ocelot PIXL P1352019-03-29
AVINGER, INC.
Lightbox Umbilical U1002019-03-29
AVINGER, INC.
Juicebox J1002019-03-29
AVINGER, INC.
Kittykat II E5502019-03-29
AVINGER, INC.
Kittykat II W5502019-03-29
AVINGER, INC.
Wildcat E4002019-03-29
AVINGER, INC.
Wildcat W4002019-03-29
Avinger, Inc.
Pantheris System2018-05-22
Avinger, Inc.
Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console, Lightbox Sled2017-10-30
Avinger, Inc.
Pantheris Catheter (8F); Pantheris Cather (7F); Lightbox HS Imaging Console; Lightbox Sled2016-12-21
Avinger, Inc
Pantheris Catheter, Lightbix HS Imaging Console, Lightbox Sled2016-10-18
AVINGER, INC.
Pantheris Catheter2016-04-21
AVINGER, INC.
Avinger Flex2016-04-12
AVINGER, INC.
Avinger CO2 Regulator System2016-03-09
AVINGER, INC.
Avinger CO2 Cartridges2016-03-09
AVINGER, INC.
Avinger Pantheris Catheter2016-03-03
AVINGER, INC.
Pantheris Catheter (8Fr), Pantheris Catheter (7Fr)2016-03-01
AVINGER, INC.
Pantheris System2016-02-03
AVINGER, INC.
Pantheris System2016-02-03
Avinger, Inc.
Pantheris System2015-10-14
AVINGER, INC.
OCELOT CATHETER, OCELOT PIXL CATHETER, LIGHTBOX CONSOLE2014-05-01
AVINGER, INC.
Ocelot PIXL Catheter2012-12-17
AVINGER, INC.
OCELOT PIXL CATHETER2012-12-14
AVINGER, INC.
Ocelot MVRX2012-12-12
AVINGER, INC.
Ocelot Catheter (O250)2012-12-12
AVINGER, INC.
OCELOT CATHETER2012-12-07
AVINGER, INC.
Umbilical U1002012-11-15
AVINGER, INC.
Ocelot Catheter O2002012-11-15
AVINGER, INC.
Lightbox Console L100 & L2002012-11-15
AVINGER, INC.
OCELOT SYSTEM2012-11-07
AVINGER, INC.
Kittycat2012-10-30
AVINGER, INC.
Kittycat 22012-10-30
AVINGER, INC.
Wildcat2012-10-30
AVINGER, INC.
Juicebox2012-10-30
AVINGER, INC.
KITTYCAT CATHETER, KITTYCAT 2 CATHETER2012-03-30
AVINGER, INC.
WILDCAT CATHETER2012-03-12
AVINGER, INC.
Kittycat 22011-11-23
AVINGER, INC.
Juicebox2011-11-23
AVINGER, INC.
Wildcat2011-11-23
AVINGER, INC.
Kittycat2011-11-23
AVINGER, INC.
WILDCAT 5F GUIDEWIRE SUPPORT CATHETER2011-10-06
AVINGER, INC.
AVINGER WILDCAT 6F GUIDEWIRE SUPPORT CATHETER AND JUICEBOX2011-09-09
AVINGER, INC.
WILDCAT CATHETER2011-08-11
AVINGER, INC.
Wildcat2010-11-09
AVINGER, INC.
WILDCAT 6F GUIDEWIRE SUPPORT CATHETER MODEL W400L AND W400S2010-08-06
AVINGER, INC.
WILDCAT 5F GUIDEWIRE SUPPORT CATHETER, MODE W5002010-08-06
AVINGER, INC.
WILDCAT 7F GUIDEWIRE SUPPORT CATHETER2009-02-02

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