510(k) K113182 ยท DXC Clamp, Vascular
EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC CATHETER
| Applicant | Edwards Lifesciences, LLC, Draper UT, US |
| Decision | Substantially Equivalent, Dec 7, 2011 |
| Received | Oct 28, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K113182
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 11, 2019 | Edwards Lifesciences, LLC IntraClude Intra-Aortic Occlusion Device, REF: ICF100, 10.5 Fr (3.5 mm) X 39.4" (100 cm), Rx Only, Sterile EO
The IntraClude intra-aortic occlusion device is indicated for use in patients undergoing Terminated |
DXC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.