510(k) K930252 ยท CAI Circuit, Breathing (W Connector, Adaptor, Y Piece)
BABYSET AND PAC (PULMONARY ASSIST CIRCUIT)
| Applicant | Bird Life Design, Carrollton TX, US |
| Decision | Substantially Equivalent, Feb 9, 1993 |
| Received | Jan 8, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K930252
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.