Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Polystan and its 1 subsidiaries with 14 510(k) clearances. The most recent is a 510(k) clearance dated Dec 4, 2002: PEDIATRIC ARTERIAL CANNULA.
| Date | Record | Source |
|---|---|---|
| Dec 4, 2002 | PEDIATRIC ARTERIAL CANNULAK023251 · DWF | 510(k) clearances |
| Aug 14, 2002 | SAFE MAXI HOLLOW FIBER OXYGENATOR, MODEL 016010K013038 · DTZ | 510(k) clearances |
| Aug 6, 2002 | SAFE MAXI VENOUS/CARDIOTOMY RESERVIOR, MODEL 016045K022281 · DTN | 510(k) clearances |
| Oct 13, 2000 | SAFE MINIK980974 · DTZ | 510(k) clearances |
| Feb 4, 1997 | SAFE MICROK953976 · DTZ | 510(k) clearances |
| Dec 4, 1991 | SAFE IIK912082 · DTZ | 510(k) clearances |
| Mar 28, 1990 | POLYSTAN HEART-LUNG MACHINE SYSTEMK894657 · DJQ | 510(k) clearances |
| Jan 18, 1990 | POLYSTAN HEATER-COOLER UNITK893940 · DWC | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
