510(k) Report

FDA applicant

Vascular Solutions Zerusa, Ltd.

Minneapolis, MN1 decision2012–20122 recalls

FDA records 1 decision for Vascular Solutions Zerusa, Ltd. (Minneapolis, MN) in 2012: 1 510(k) clearance. All are in product code DTL (Adaptor, Stopcock, Manifold, Fitting…). Its devices cite 1 predicate, 0 of them its own earlier devices. 2 recalls are linked to its devices, 2 Class I.

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 Vascular Solutions Zerusa, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2012: 1
2012high 1 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

1in 2016

2013: 1, 1 Class I2016: 1, 1 Class I
2012high 1 (2013) · low 0 (2012)2026

Class I Class II/III not classified

FIG. 1 — Vascular Solutions Zerusa, Ltd. by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 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.

  • K122301Guardian II Hemostasis Valve Guardian II NC Hemostasis ValveVascular Solutions Zerusa, Ltd. · 20121cites it

What has FDA decided for it lately?

  • K122301Guardian II Hemostasis Valve Guardian II NC Hemostasis ValveVascular Solutions Zerusa, Ltd. · 20122 Class I recalls

The one decision as Vascular Solutions Zerusa, Ltd. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K122301Guardian II Hemostasis Valve, models 8210 and 8211. The following models are only…Mar 4, 2016Class I
  • K092711Vascular Solutions, Inc., Guardian II and Guardian II NC Hemostasis Valve, used in…Feb 27, 2013Class I