510(k) K153479 ยท NQQ System, Imaging, Optical Coherence Tomography (Oct)
NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking Probe, 17mm balloon,NvisionVLE Marking Probe, 14mm balloon, NvisionVLE Inflation System
| Applicant | Ninepoint Medical, Inc., Bedford MA, US |
| Decision | Unknown, Feb 16, 2016 |
| Received | Dec 2, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153479
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.