510(k) K973057 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
1.4 FR MAPCATH SENSOR STYLET
| Applicant | Navion Biomedical Corp., Stoughton MA, US |
| Decision | Substantially Equivalent, Nov 12, 1997 |
| Received | Aug 15, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973057
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.