510(k) K980438 ยท MPB Catheter, Hemodialysis, Non-Implanted
11.5F X 6 (15CM) DUO-SPLIT CATHETER MCDS116MT, 11.5F X 8 (20CM) DUO-SPLIT CATHETER MCDS118MT
| Applicant | Medical Components, Inc., Harleysville PA, US |
| Decision | Substantially Equivalent, Jun 10, 1999 |
| Received | Feb 4, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980438
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.