510(k) Report

FDA applicant

Avinger, Inc.

Redwood City, CA25 decisions2009–20230 recalls

FDA records 25 decisions for Avinger, Inc. (Redwood City, CA) from 2009 to 2023: 25 510(k) clearances. Most are in product codes PDU (Catheter For Crossing Total Occlusions) and MCW (Catheter, Peripheral, Atherectomy). Since 2016 its 510(k)s took a median of 97 days from receipt to decision, against 103 for FDA’s reviews in the same codes and years. Its devices cite 36 predicates, 28 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Avinger, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2023

2009: 12010: 22011: 32012: 52014: 12015: 12016: 42017: 12018: 12019: 12020: 12021: 12022: 12023: 2
2009high 5 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Avinger, Inc. by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Avinger, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • PDUCatheter For Crossing Total Occlusions10decisions
  • MCWCatheter, Peripheral, Atherectomy10decisions
  • DQYCatheter, Percutaneous5decisions

How long do its 510(k) reviews take?

Since 2016, its 11 510(k)s took a median of 97 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 103 days; 3 of its 11 were faster than that.

Whose devices does it build on?

Its devices cite 36 predicates; 28 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 29 times; 28 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K111338Wildcat CatheterAvinger, Inc. · 20113cite it
  • K201330Tigereye CTO-Crossing CatheterAvinger, Inc. · 20203cite it
  • K122380Ocelot SystemAvinger, Inc. · 20123cite it
  • K111704Avinger Wildcat 6F Guidewire Support Catheter and JuiceboxAvinger, Inc. · 20112cite it
  • K123532Ocelot Pixl CatheterAvinger, Inc. · 20122cite it
  • K101647Wildcat 5F Guidewire Support Catheter, Mode W500Avinger, Inc. · 20102cite it

What has FDA decided for it lately?

  • K230005Pantheris LV Atherectomy CatheterAvinger, Inc. · 2023
  • K230594Tigereye ST CTO-Crossing CatheterAvinger, Inc. · 2023
  • K212468Tigereye CTO-Crossing CatheterAvinger, Inc. · 2022
  • K212047Pantheris SystemAvinger, Inc. · 2021
  • K201330Tigereye CTO-Crossing CatheterAvinger, Inc. · 2020
  • K182341Pantheris SVAvinger, Inc. · 2019
  • K173862Pantheris SystemAvinger, Inc. · 2018
  • K172236Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console, Lightbox SledAvinger, Inc. · 2017

All 25 as Avinger, Inc. →