510(k) Report

FDA applicant

R4 Vascular, Inc.

Maple Grove, MN7 decisions2007–20131 recall

FDA records 7 decisions for R4 Vascular, Inc. (Maple Grove, MN) from 2007 to 2013: 7 510(k) clearances. Most are in product codes LJS (Catheter, Intravascular, Therapeutic…) and MSD (Catheter, Hemodialysis, Implanted). Its devices cite 3 predicates, 1 of them its own earlier devices. 1 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, general hospital panel, where it files most

How often FDA has decided R4 Vascular, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2007: 12009: 22010: 22012: 12013: 1
2007high 2 (2009) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2011

2011: 1
2007high 1 (2011) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — R4 Vascular, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like R4 Vascular, 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?

  • LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days3decisions
  • MSDCatheter, Hemodialysis, Implanted2decisions
  • LITCatheter, Angioplasty, Peripheral, Transluminal2decisions

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 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.

  • K083763Zeus CT Picc 4 FR and 5 FR Single and Dual LumenR4 Vascular, Inc. · 20093cite it
  • K091506Duraspan Hemodialysis Long-Term Catheter, Models 62152420, 621512820, 62153220, 62153620, 62154020, 62155520R4 Vascular, Inc. · 20101cites it
  • K121385VectorR4 Vascular, Inc. · 20121cites it
  • K131329Vector Pta Balloon Dilatation CatheterR4 Vascular, Inc. · 20131cites it

What has FDA decided for it lately?

  • K131329Vector Pta Balloon Dilatation CatheterR4 Vascular, Inc. · 2013
  • K121385VectorR4 Vascular, Inc. · 2012
  • K100169Duraspan Hemodialysis Long-Term CatheterR4 Vascular, Inc. · 20101 recall
  • K091506Duraspan Hemodialysis Long-Term Catheter, Models 62152420, 621512820, 62153220, 62153620, 62154020, 62155520R4 Vascular, Inc. · 20101 recall
  • K092040Pherocious 10.5 FR (24 CM, 28 CM and 32 CM), Models 430102440, 430102840, 430103240R4 Vascular, Inc. · 2009
  • K083763Zeus CT Picc 4 FR and 5 FR Single and Dual LumenR4 Vascular, Inc. · 2009
  • K071361R4 Vascular Inc. Pegasus CT Picc, Model 500005-001,002, 004, 005, 500004-001, 002,004,005R4 Vascular, Inc. · 2007

All 7 as R4 Vascular, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K091506DuraspanTM Dialysis Catheters, Ultra and Long Term, 15.5 Fr, Sterile EO, Manufactured…May 3, 2011