510(k) Report

FDA applicant

Vascon, LLC

Miami, FL4 decisions2004–200824 recalls

FDA records 4 decisions for Vascon, LLC (Miami, FL) from 2004 to 2008: 4 510(k) clearances. Most are in product codes DQY (Catheter, Percutaneous) and KRA (Catheter, Continuous Flush). Its devices cite 1 predicate, 1 of them its own earlier devices. 24 recalls are 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 Vascon, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

24in 2013

2013: 24
2007high 24 (2013) · low 0 (2007)2026

Class I Class II/III not classified

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

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Which product codes does it file in?

  • DQYCatheter, Percutaneous3decisions
  • KRACatheter, Continuous Flush1decision

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.

  • K043387Vascon Polaris Guiding CatheterVascon, LLC · 20052cite it
  • K033633Vascon Polaris Guiding CatheterVascon, LLC · 20041cites it

What has FDA decided for it lately?

  • K053310Vascon Roamer MicrocatheterVascon, LLC · 2008
  • K052004Vascon Neuropath Guiding CatheterVascon, LLC · 200624 recalls
  • K043387Vascon Polaris Guiding CatheterVascon, LLC · 2005
  • K033633Vascon Polaris Guiding CatheterVascon, LLC · 2004

All 4 as Vascon, LLC →

What has been recalled?

24 recalls linked to its devices; the latest:

  • K052004NEUROPATH 5Fx100 GUIDING CATH HH Product Code: GHH51000000 Intended for use in the…Jan 11, 2013Class II
  • K052004NEUROPATH 5Fx100 GUIDING CATH MP Product Code:GMD51000000 Intended for use in the…Jan 11, 2013Class II
  • K052004NEUROPATH 6Fx90 GUIDING CATH ST Product Code: GST60900000 Intended for use in the…Jan 11, 2013Class II
  • K052004NEUROPATH 6Fx100 GUIDING CATH MP Product Code: GMC61000000 Intended for use in the…Jan 11, 2013Class II
  • K052004NEUROPATH 6Fx90 GUIDING CATH HH Product Code: GHH60900000 Intended for use in the…Jan 11, 2013Class II
  • K052004NEUROPATH 5Fx100 GUIDING CATH HH Product Code: GMC51000000 Intended for use in the…Jan 11, 2013Class II