510(k) K013160 ยท MSD Catheter, Hemodialysis, Implanted
POURCHEZ XPRESSO TWIN LIMEN CHRONIC HEMODIALYSIS CATHETER
| Applicant | Spire Biomedical, Inc., Bedford MA, US |
| Decision | Substantially Equivalent, Apr 11, 2002 |
| Received | Sep 21, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013160
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.