Polystan C/O Vitalcor, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Polystan C/O Vitalcor, Inc.” (first 1984, latest 1990), across 7 product codes in 2 review panels. Median 510(k) review time under this name: 181 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 |
|---|---|---|---|
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 2 | 2 |
| DJQ | Test Reagents For Phenothiazine | 1 | 1 |
| DQY | Catheter, Percutaneous | 1 | 1 |
| DRY | Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass | 1 | 1 |
| DTN | Reservoir, Blood, Cardiopulmonary Bypass | 1 | 1 |
| DTZ | Oxygenator, Cardiopulmonary Bypass | 1 | 1 |
| DWC | Controller, Temperature, Cardiopulmonary Bypass | 1 | 1 |
Review panels
Most recent Polystan C/O Vitalcor, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K894657 | POLYSTAN HEART-LUNG MACHINE SYSTEM | DJQ | 1990-03-28 | 247 |
| K893940 | POLYSTAN HEATER-COOLER UNIT | DWC | 1990-01-18 | 232 |
| K893705 | SAFE-1 VENOUS RESERVOIR | DTN | 1989-12-22 | 218 |
| K893704 | SAFE-1 | DTZ | 1989-12-22 | 218 |
| K874853 | POLYSTAN TWO STAGE CATHETERS | DWF | 1988-02-05 | 72 |
| K874852 | POLYSTAN WIRE REINFORCED TWO STAGE CATHETERS | DWF | 1988-02-05 | 72 |
| K872182 | POLYSTAN WIRE REINFORCED CATHETERS AND CANNULAE | DQY | 1987-10-30 | 144 |
| K843538 | PO 2 LYTRODE | DRY | 1984-10-18 | 41 |
Recalls
openFDA lists no recalls under a recalling firm named Polystan C/O Vitalcor, Inc..
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 A/S (6 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Polystan C/O Vitalcor, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Polystan C/O Vitalcor, Inc.” (first 1984, latest 1990), across 7 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Polystan C/O Vitalcor, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Polystan C/O Vitalcor, Inc. is 181 days.
Which FDA product codes appear under Polystan C/O Vitalcor, Inc.?
The most frequent FDA product codes under this applicant name are DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass, 2); DJQ (Test Reagents For Phenothiazine, 1); DQY (Catheter, Percutaneous, 1).
Next steps
- See all 8 Polystan C/O Vitalcor, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DWF, Polystan C/O Vitalcor, Inc.'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.