510(k) K073093 ยท MSD Catheter, Hemodialysis, Implanted
DECATHLON GOLD TWIN LUMEN HEMODIALYSIS CATHETER WITH SEPARATED TIPS, MODELS DEC19SH24, DEC23SH28, DEC23SH32, DEC31SH36,
| Applicant | Spire Biomedical, Inc., Bedford MA, US |
| Decision | Substantially Equivalent, Jan 22, 2008 |
| Received | Nov 1, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K073093
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.