FDA applicant

Polystan C/O Vitalcor, Inc.

Denmark, DK8 decisions1984–19900 recalls

FDA records 8 decisions for Polystan C/O Vitalcor, Inc. (Denmark, DK) from 1984 to 1990: 8 510(k) clearances. Most are in product codes DWF (Catheter, Cannula And Tubing, Vascular…) and DRY (Monitor, Blood-Gas, On-Line, Cardiopulmonary…). No 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 C/O Vitalcor, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Polystan C/O Vitalcor, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Polystan C/O Vitalcor, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Polystan”

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

Polystan A/S 6

Polystan C/O Vitalcor, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Polystan”