510(k) K143613 ยท MJN Catheter, Intravascular Occluding, Temporary
PaxWire Occlusion Balloon System
| Applicant | Accessclosure, Inc., Santa Clara CA, US |
| Decision | Substantially Equivalent, Aug 14, 2015 |
| Received | Dec 19, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143613
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 6, 2016 | AccessClosure, Inc., A Cardinal Health Company The PAXWIRE Occlusion Balloon System consists of an occlusion catheter, inflation handle and syringes. It is designed for use in the iliofemoral artery to provide temporary occlusion as well as a path Terminated |
MJN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.