510(k) K163693 ยท DXC Clamp, Vascular
IntraClude Intra-Aortic Occlusion Device
| Applicant | Edwards Lifesciences, LLC, Irvine CA, US |
| Decision | Substantially Equivalent, Jan 26, 2017 |
| Received | Dec 28, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K163693
| 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 |
| Jan 16, 2019 | Edwards Lifesciences, LLC Edwards Lifesciences(R) IntraClude(TM) Intra-Aortic Occlusion Device
is a 10.5 Fr (3.5mm), triple lumen, 100cm long catheter with an elastomeric balloon near its distal tip designed to occlude the a Open, Classified |
DXC | None listed |
| Mar 30, 2018 | Edwards Lifesciences, LLC Edwards Lifesciences' IntraClude Intra-Aortic Occlusion Device. Packaged in a sterile barrier system. Model Number: ICF100.
Designed to occlude the ascending aorta. Terminated |
DXC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.