510(k) K092486 ยท DWE Tubing, Pump, Cardiopulmonary Bypass
VORTEX MEDICAL ANGIOVAC CARDIOPULMONARY BYPASS CIRCUIT
| Applicant | Vortex Medical, Inc., Glens Falls NY, US |
| Decision | Substantially Equivalent, Aug 28, 2009 |
| Received | Aug 13, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092486
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 20, 2016 | Angiodynamics Inc. (Navilyst Medical Inc.) Vortex MEDICAL AngioVac Circuit, REF/UPN VTX3100, STERILE, Rx Only, Single Use Only -- The AngioVac Circuit and AngioVac Circuit Pack are designed to be used with the AngioVac Cannula. Terminated |
DWE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.