510(k) K100451 ยท MPB Catheter, Hemodialysis, Non-Implanted
GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1315 A; AND MS-GDHC-1315J A, GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1320 A; AND MS-GDHC-132
| Applicant | Gambro Renal Products, Inc., Lakewood CO, US |
| Decision | Substantially Equivalent, Dec 21, 2010 |
| Received | Feb 17, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100451
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.