Polystan A/S: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Polystan A/S” (first 1991, latest 2002), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 273 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DTZ | Oxygenator, Cardiopulmonary Bypass | 4 | 4 |
| DTN | Reservoir, Blood, Cardiopulmonary Bypass | 1 | 1 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 1 | 1 |
Review panels
- Cardiovascular (6)
Most recent Polystan A/S 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K023251 | PEDIATRIC ARTERIAL CANNULA | DWF | 2002-12-04 | 65 |
| K013038 | SAFE MAXI HOLLOW FIBER OXYGENATOR, MODEL 016010 | DTZ | 2002-08-14 | 338 |
| K022281 | SAFE MAXI VENOUS/CARDIOTOMY RESERVIOR, MODEL 016045 | DTN | 2002-08-06 | 22 |
| K980974 | SAFE MINI | DTZ | 2000-10-13 | 942 |
| K953976 | SAFE MICRO | DTZ | 1997-02-04 | 531 |
| K912082 | SAFE II | DTZ | 1991-12-04 | 208 |
Recalls
openFDA lists no recalls under a recalling firm named Polystan A/S.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Polystan C/O Vitalcor, Inc. (8 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Polystan A/S?
FDA lists 6 510(k) clearances under the applicant name “Polystan A/S” (first 1991, latest 2002), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Polystan A/S?
The median time from FDA receipt to decision across 510(k)s cleared under the name Polystan A/S is 273 days.
Which FDA product codes appear under Polystan A/S?
The most frequent FDA product codes under this applicant name are DTZ (Oxygenator, Cardiopulmonary Bypass, 4); DTN (Reservoir, Blood, Cardiopulmonary Bypass, 1); DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass, 1).
Next steps
- See all 6 Polystan A/S clearances with predicates and recalls
- Run predicate analysis for product code DTZ, Polystan A/S's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.