510(k) K102238 ยท MSD Catheter, Hemodialysis, Implanted
ARROW(R) NEXTSTEP TM ANTEGRADE CHRONIC HEMODIALYSIS CATHETER
| Applicant | Teleflexmedical, Inc., Reading PA, US |
| Decision | Substantially Equivalent, Feb 1, 2011 |
| Received | Aug 9, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K102238
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 30, 2011 | Arrow International Inc Arrow NextStep Antegrade Chronic Hemodialysis Catheter.
Product is used for attaining long-term vascular access for hemodialysis and apheresis. Terminated |
MSD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.