510(k) Report

FDA applicant

Velocimed, Inc.

Minneapolis, MN6 decisions2003–20062 recalls

FDA records 6 decisions for Velocimed, Inc. (Minneapolis, MN) from 2003 to 2006: 6 510(k) clearances. Most are in product codes DQY (Catheter, Percutaneous) and DYB (Introducer, Catheter). Its devices cite 17 predicates, 3 of them its own earlier devices. 2 recalls are linked to its devices, 1 Class I.

FDA’s records also spell it “Velocimed”.

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 Velocimed, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Velocimed, Inc. since 2007.

Recalls per year

1in 2018

2017: 1, 1 Class I2018: 1
2007high 1 (2017) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Velocimed, 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?

  • DQYCatheter, Percutaneous4decisions
  • DYBIntroducer, Catheter1decision
  • NFATemporary Coronary Saphenous Vein Bypass Graft For Embolic Protection1decision

Whose devices does it build on?

Its devices cite 17 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 12 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.

  • K042117Proxis System, Model Eps 101Velocimed, Inc. · 20053cite it
  • K042910Venture Wire Control Catheter, Model WCCVelocimed, Inc. · 20043cite it
  • K052523Proxis SystemVelocimed, Inc. · 20062cite it
  • K040922Venture Wire Control CatheterVelocimed, Inc. · 20042cite it
  • K023548Proxis Flow-Control Device, Models Eps 101, IC 101Velocimed · 20031cites it
  • K043084Premere Delivery Sheath, Model PDSVelocimed, Inc. · 20051cites it

What has FDA decided for it lately?

  • K052523Proxis SystemVelocimed, Inc. · 2006
  • K043084Premere Delivery Sheath, Model PDSVelocimed, Inc. · 2005
  • K042117Proxis System, Model Eps 101Velocimed, Inc. · 2005
  • K042910Venture Wire Control Catheter, Model WCCVelocimed, Inc. · 20041 Class I recall
  • K040922Venture Wire Control CatheterVelocimed, Inc. · 20041 Class I recall
  • K023548Proxis Flow-Control Device, Models Eps 101, IC 101Velocimed · 2003

All 5 as Velocimed, Inc. →The one decision as Velocimed →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K042910Vascular Solutions Venture Rx Catheter, 6F, resterilized.Mar 7, 2018Class II
  • K042910Venture RX Catheter, Model 5820; Venture OTW Catheter, Model 5821; Venture CS Catheter…Apr 25, 2017Class I