510(k) K061070 ยท DRC Trocar
HANSEN MEDICAL TRANSSEPTAL NEEDLE AND DILATOR
| Applicant | Hansen Medical, Inc., Mountain View CA, US |
| Decision | Substantially Equivalent, Oct 13, 2006 |
| Received | Apr 17, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061070
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.