510(k) K141769 ยท DQO Catheter, Intravascular, Diagnostic
OPTIS INTEGRATED SYSTEM, DRAGONFLY OPTIS IMAGING CATHETER
| Applicant | Lightlab Imaging, Inc., Westford MA, US |
| Decision | Substantially Equivalent, Aug 18, 2014 |
| Received | Jul 1, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K141769
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.