510(k) K132175 ยท DXC Clamp, Vascular
EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC CATHETER
| Applicant | Edwards Lifesciences, LLC, Draper UT, US |
| Decision | Substantially Equivalent, Sep 13, 2013 |
| Received | Jul 15, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K132175
| 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 |
| Jun 11, 2015 | Edwards Lifesciences, LLC Edwards Lifesciences IntraClude Intra-Aortic Occlusion Device, model number ICF100, 10.5 Fr (3.5 mm) x 39.4" (100 cm) ThruPort System. Packaged sterile and non-pyrogenic in a sealed, peel-type pouch
Terminated |
DXC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.