Company
VIASYS Med Systems
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
8recalls (0 in 12 months)
8recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 4, 2005 | VIASYS Med Systems Stackhouse Lens/Hood, Mark III Universal; a sterile disposable protective head garment for use with the Stackhouse Mark III Helmet, providing a clear plastic bubble lens and protective head hood to co Terminated |
FXY | K910515 |
| Oct 4, 2005 | VIASYS Med Systems Stackhouse FreedomAire Lens/Hood; a sterile disposable protective head garment for use with the FreedomAire Surgical Helmet System, providing a clear plastic bubble lens and protective head hood to co Terminated |
FXY | K910515 |
| Oct 15, 2003 | VIASYS Med Systems Sideport Kit w/Oxygen Line, consisting of an adjustable sideport valve, an O2 port elbow and O2 supply tubing; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83167 Terminated |
CAI | K930252 |
| Oct 15, 2003 | VIASYS Med Systems Sideport Kit, consisting of an adjustable sideport valve and an O2 port elbow; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83166 Terminated |
CAI | K930252 |
| Oct 15, 2003 | VIASYS Med Systems Hyperinflation Circuit, consisting of a 2.0 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve and ported elbow; Mfg. for Corpak MedSystems Terminated |
CAI | K930252 |
| Oct 15, 2003 | VIASYS Med Systems Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve, 40 cm H2O Popoff elbow and Terminated |
CAI | K930252 |
| Oct 15, 2003 | VIASYS Med Systems Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve, ported elbow and infant mas Terminated |
CAI | K930252 |
| Oct 15, 2003 | VIASYS Med Systems Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube with Bird adapter, oxygen supply tubing, sideport connector with adjustable bleed valve, and 40 cm Terminated |
CAI | K930252 |