510(k) Report

FDA applicant

Coaxia, Inc.

Maple Grove, MN2 decisions2003–20090 recalls

FDA records 2 decisions for Coaxia, Inc. (Maple Grove, MN) from 2003 to 2009: 2 510(k) clearances. All are in product code MJN (Catheter, Intravascular Occluding, Temporary). Its devices cite 5 predicates, 1 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 Coaxia, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Coaxia, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Coaxia, 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?

  • MJNCatheter, Intravascular Occluding, Temporary2decisions

Whose devices does it build on?

Its devices cite 5 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 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.

  • K023914Coaxia Flocontrol CatheterCoaxia, Inc. · 20032cite it
  • K090970Flocontrol , Model 1028Coaxia, Inc. · 20091cites it

What has FDA decided for it lately?

  • K090970Flocontrol , Model 1028Coaxia, Inc. · 2009
  • K023914Coaxia Flocontrol CatheterCoaxia, Inc. · 2003

All 2 as Coaxia, Inc. →