510(k) Report

FDA applicant

Vascular Pathways, Inc.

Naples, FL4 decisions2008–20150 recalls

FDA records 4 decisions for Vascular Pathways, Inc. (Naples, FL) from 2008 to 2015: 4 510(k) clearances. All are in product code FOZ (Catheter, Intravascular, Therapeutic…). Its devices cite 7 predicates, 3 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Vascular Pathways”.

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

FIG. A — Illustration, general hospital panel, where it files most

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

FDA decisions per year

1in 2015

2008: 12011: 12014: 12015: 1
2008high 1 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

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

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

See the 510(k) Report

Which product codes does it file in?

  • FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days4decisions

Whose devices does it build on?

Its devices cite 7 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 3 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.

  • K112347Rapid Intravascular Catheter Start System 22 Gauge / 20 Gauge / 18 GaugeVascular Pathways, Inc. · 20113cite it
  • K140504Accucath BC Intravascular Catheter SystemVascular Pathways, Inc. · 20142cite it
  • K073241Vascular Pathways Rivs Rapid Intravascular Catheter Start SystemVascular Pathways · 20081cites it

What has FDA decided for it lately?

  • K142136Accucath Midline Catheter SystemVascular Pathways, Inc. · 2015
  • K140504Accucath BC Intravascular Catheter SystemVascular Pathways, Inc. · 2014
  • K112347Rapid Intravascular Catheter Start System 22 Gauge / 20 Gauge / 18 GaugeVascular Pathways, Inc. · 2011
  • K073241Vascular Pathways Rivs Rapid Intravascular Catheter Start SystemVascular Pathways · 2008

All 3 as Vascular Pathways, Inc. →The one decision as Vascular Pathways →