510(k) K141453 ยท DQO Catheter, Intravascular, Diagnostic
ILUMIEN OPTIS, DRAGONFLY OPTIS IMAGING CATHETER
| Applicant | Lightlab Imaging, Inc., Westford MA, US |
| Decision | Substantially Equivalent, Sep 19, 2014 |
| Received | Jun 2, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K141453
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.