510(k) K082075 ยท DRE Dilator, Vessel, For Percutaneous Catheterization
HANSEN MEDICAL DILATOR FOR ARTISAN CONTROL CATHETER
| Applicant | Hansen Medical, Inc., Mountain View CA, US |
| Decision | Substantially Equivalent, Aug 15, 2008 |
| Received | Jul 23, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K082075
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.