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Avinger, Inc.

United StatesFDA applicant, unverified

Avinger, Inc. is a medical device manufacturer, with 44 devices listed in FDA 510(k) and FDA GUDID (FDA Class II and I) as of 14 Nov 2026.

Devices
44

Registry facts

Counted by deviCERTS from registry records, 14 Nov 2026

Registries
  • FDA 510(k) 25
  • FDA GUDID 19

A device listed in two registries counts in both.

Device classes
  • FDA Class II 42
  • FDA Class I 2
Identifiers
  • DUNS 003152968

What Avinger, Inc. makes

Avinger, Inc. manufactures mechanical atherectomy systems for coronary and peripheral arteries, including catheters designed for plaque removal and vessel crossing, such as the Wildcat and Tigereye ST. Their portfolio also includes torque manipulation devices like the Pantheris and Ocelot series, as well as single-use surgical drapes for procedural environments. Additional products include microdissection catheters for precise plaque removal and mechanical output generators for atherectomy systems.

The company’s devices are regulated under FDA classifications, with most falling into Class I and Class II categories. Products are listed via 510(k) clearances and the FDA’s Unique Device Identifier (UDI) system.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue44

Newest first, rows 1-44 of 44

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Company details

DUNS number
003152968
Phone
650-241-7030

Frequently asked questions

How many devices does AVINGER, INC. have in the registry?

The registry currently lists 44 devices for AVINGER, INC.. Devices recorded under merged duplicate company entries are counted once.

Which registries list AVINGER, INC.'s devices?

Among its 44 most recently registered devices, AVINGER, INC. has devices listed in FDA 510(k) (25 devices) and FDA GUDID (19 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do AVINGER, INC.'s devices fall under?

Among its 44 most recently registered devices, the classes recorded for AVINGER, INC.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from AVINGER, INC. in the registry?

The most recently registered devices listed for AVINGER, INC. include Wildcat W400, Tigereye ST O350, Sterile Drape SD100 and Pantheris A400.

Generated automatically from registry data and not verified by a human reviewer.