510(k) K142607 ยท DWE Tubing, Pump, Cardiopulmonary Bypass
AngioVac Circuit
| Applicant | Angiodynamics, Marlborough MA, US |
| Decision | Substantially Equivalent, Dec 11, 2014 |
| Received | Sep 15, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142607
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 20, 2016 | Angiodynamics Inc. (Navilyst Medical Inc.) AngioVac Circuit Pack (Tandem Packs), REF/Catalog No. 25-187, UPN H965251870, STERILE, Rx Only, Single Use Only -- The AngioVac Circuit and AngioVac Circuit Pack are designed to be used with the Angio Terminated |
DWE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.