510(k) K021212 ยท MSD Catheter, Hemodialysis, Implanted
24CM POURCHEZ XPRESSO TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS
| Applicant | Spire Biomedical, Inc., Bedford MA, US |
| Decision | Substantially Equivalent, May 17, 2002 |
| Received | Apr 17, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K021212
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.