510(k) K091506 ยท MSD Catheter, Hemodialysis, Implanted
DURASPAN HEMODIALYSIS LONG-TERM CATHETER, MODELS 62152420, 621512820, 62153220, 62153620, 62154020, 62155520
| Applicant | R4 Vascular, Inc., Maple Grove MN, US |
| Decision | Unknown, Jan 8, 2010 |
| Received | May 21, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K091506
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 6, 2011 | R4 Vascular Inc DuraspanTM Dialysis Catheters, Ultra and Long Term, 15.5 Fr, Sterile EO, Manufactured for r4 Vascular, Inc . 7550 Meridan Circle North, Suite 150, Maple Grove, MN 55369.
Description Terminated |
MSD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.