510(k) Report

FDA applicant

Precision Vascular Systems, Inc.

West Valley City, UT7 decisions1999–20032 recalls

FDA records 7 decisions for Precision Vascular Systems, Inc. (West Valley City, UT) from 1999 to 2003: 7 510(k) clearances. Most are in product codes DQX (Wire, Guide, Catheter) and KRA (Catheter, Continuous Flush). Its devices cite 14 predicates, 2 of them its own earlier devices. 2 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 Precision Vascular Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Precision Vascular Systems, Inc. since 2007.

Recalls per year

2in 2024

2024: 2
2007high 2 (2024) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Precision Vascular Systems, 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?

  • DQXWire, Guide, Catheter5decisions
  • KRACatheter, Continuous Flush2decisions

Whose devices does it build on?

Its devices cite 14 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 11 times; 2 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.

  • K032146PVS 1300 Synchro 0.014 & PVS 1600 Synchro 0.010 Guide WiresPrecision Vascular Systems, Inc. · 20034cite it
  • K032494PVS 1700 Steerable Delivery System MicrocatheterPrecision Vascular Systems, Inc. · 20033cite it
  • K020733PVS 1500 SDSPrecision Vascular Systems, Inc. · 20023cite it
  • K002907PVS 1300 Neuro Guide WirePrecision Vascular Systems, Inc. · 20011cites it

What has FDA decided for it lately?

  • K032494PVS 1700 Steerable Delivery System MicrocatheterPrecision Vascular Systems, Inc. · 2003
  • K032146PVS 1300 Synchro 0.014 & PVS 1600 Synchro 0.010 Guide WiresPrecision Vascular Systems, Inc. · 20031 recall
  • K023700PVS 1600 Synchro 0.010 Neuro Guide WirePrecision Vascular Systems, Inc. · 20021 recall
  • K020733PVS 1500 SDSPrecision Vascular Systems, Inc. · 2002
  • K002907PVS 1300 Neuro Guide WirePrecision Vascular Systems, Inc. · 20011 recall
  • K002707PVS 1400 Guide Wite with Hydrophilic CoatingPrecision Vascular Systems, Inc. · 2000
  • K990823PVS 1400 GuidewirePrecision Vascular Systems, Inc. · 1999

All 7 as Precision Vascular Systems, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K023700Synchro .014"guide wire, 35 cm tip, Catalog: M00313010 Synchro .014 guide wire, 300 cm…Apr 23, 2024Class II
  • K032146The Synchro Neuro Guidewires are a steerable guidewire family with a shapeable tip. The…Apr 18, 2024Class II