510(k) Report

FDA applicant

Polystan A/S

Vaerlose, DK6 decisions1991–20021 recall

FDA records 6 decisions for Polystan A/S (Vaerlose, DK) from 1991 to 2002: 6 510(k) clearances. Most are in product codes DTZ (Oxygenator, Cardiopulmonary Bypass) and DWF (Catheter, Cannula And Tubing, Vascular…). Its devices cite 4 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, cardiovascular panel, where it files most

How often FDA has decided Polystan A/S’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Polystan A/S since 2007.

Recalls per year

1in 2012

2012: 1
2007high 1 (2012) · low 0 (2007)2026

Class I Class II/III not classified

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

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Which product codes does it file in?

  • DTZOxygenator, Cardiopulmonary Bypass4decisions
  • DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass1decision
  • DTNReservoir, Blood, Cardiopulmonary Bypass1decision

Whose devices does it build on?

Its devices cite 4 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 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.

  • K953976Safe MicroPolystan A/S · 19971cites it
  • K980974Safe MiniPolystan A/S · 20001cites it

What has FDA decided for it lately?

  • K023251Pediatric Arterial CannulaPolystan A/S · 20021 recall
  • K013038Safe Maxi Hollow Fiber Oxygenator, Model 016010Polystan A/S · 2002
  • K022281Safe Maxi Venous/Cardiotomy Reservior, Model 016045Polystan A/S · 2002
  • K980974Safe MiniPolystan A/S · 2000
  • K953976Safe MicroPolystan A/S · 1997
  • K912082Safe IIPolystan A/S · 1991

All 6 as Polystan A/S →

What has been recalled?

1 recall linked to its devices; the latest:

  • K023251Maquet Getinge Group Pediatric Arterial Cannula Maquet Cardiopulmonary AG Kehler Strabe…May 29, 2012Class II

Other applicant names beginning “Polystan”

FDA records each applicant name separately; these may or may not be the same firm.

Polystan C/O Vitalcor, Inc. 8