510(k) K073092 ยท MSD Catheter, Hemodialysis, Implanted
DECATHLON TWIN LUMEN HEMODIALYSIS CATHETER WITH SEPARATED TIPS, MODELS DE19SH24, DE23SH28, DE27SH32, DE31SH36, DE35SH40,
| Applicant | Spire Biomedical, Inc., Bedford MA, US |
| Decision | Substantially Equivalent, Jan 29, 2008 |
| Received | Nov 1, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K073092
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.