510(k) Report

FDA applicant

Walk Vascular, LLC

Irvine, CA9 decisions2012–20220 recalls

FDA records 9 decisions for Walk Vascular, LLC (Irvine, CA) from 2012 to 2022: 9 510(k) clearances. All are in product code QEZ (Aspiration Thrombectomy Catheter). Since 2016 its 510(k)s took a median of 113 days from receipt to decision, against 112 for FDA’s reviews in the same codes and years. Its devices cite 12 predicates, 6 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 Walk Vascular, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2012: 12014: 12016: 12017: 22019: 22020: 12022: 1
2012high 2 (2017) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Walk Vascular, LLC by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • QEZAspiration Thrombectomy Catheter9decisions

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 113 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 112 days; 0 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 12 predicates; 6 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 6 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.

  • K183403JETi 88 Peripheral Thrombectomy SystemWalk Vascular, LLC · 20192cite it
  • K120508Clearlumen Thrombectomy SystemWalk Vascular, LLC · 20121cites it
  • K213565JETi AIO Peripheral Thrombectomy SystemWalk Vascular, LLC · 20221cites it
  • K161786ClearLumen II Thrombectomy SystemWalk Vascular, LLC · 20161cites it
  • K201998JETi AIO Peripheral Thrombectomy SystemWalk Vascular, LLC · 20201cites it
  • K140296Clearlumen Thrombectomy SystemWalk Vascular, LLC · 20141cites it

What has FDA decided for it lately?

  • K213565JETi AIO Peripheral Thrombectomy SystemWalk Vascular, LLC · 2022
  • K201998JETi AIO Peripheral Thrombectomy SystemWalk Vascular, LLC · 2020
  • K192439JETi Peripheral Thrombectomy SystemWalk Vascular, LLC · 2019
  • K183403JETi 88 Peripheral Thrombectomy SystemWalk Vascular, LLC · 2019
  • K172000ClearLumen II Peripheral Thrombectomy SystemWalk Vascular, LLC · 2017
  • K163051ClearLumen II Peripheral Thrombectomy SystemWalk Vascular, LLC · 2017
  • K161786ClearLumen II Thrombectomy SystemWalk Vascular, LLC · 2016
  • K140296Clearlumen Thrombectomy SystemWalk Vascular, LLC · 2014

All 9 as Walk Vascular, LLC →

Other applicant names beginning “Walk”

FDA records each applicant name separately; these may or may not be the same firm.

Walk on Wheels Australia Pty, Ltd. 1Walk-A-Cycle Division 1