510(k) Report

FDA applicant

Vascular Insights, LLC

Madison, CT2 decisions2008–20161 recall

FDA records 2 decisions for Vascular Insights, LLC (Madison, CT) from 2008 to 2016: 2 510(k) clearances. All are in product code KRA (Catheter, Continuous Flush). Its devices cite 3 predicates, 1 of them its own earlier devices. 1 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 Vascular Insights, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2008: 12016: 1
2008high 1 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

1in 2017

2017: 1
2008high 1 (2017) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Vascular Insights, LLC by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • KRACatheter, Continuous Flush2decisions

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 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.

  • K071468Clarivein CatheterVascular Insights, LLC · 20081cites it
  • K153502ClariVein ICVascular Insights, LLC · 20161cites it

What has FDA decided for it lately?

  • K153502ClariVein ICVascular Insights, LLC · 2016
  • K071468Clarivein CatheterVascular Insights, LLC · 20081 recall

All 2 as Vascular Insights, LLC →

What has been recalled?

1 recall linked to its devices; the latest:

  • K071468ClariVein IC infusion catheter, Model Number: 65-018-E4S Product Usage: The ClariVein IC…Nov 9, 2017Class II