510(k) K143678 ยท NQQ System, Imaging, Optical Coherence Tomography (Oct)
NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation Accessory
| Applicant | Ninepoint Medical, Inc., Cambridge MA, US |
| Decision | Unknown, Feb 6, 2015 |
| Received | Dec 24, 2014 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K143678
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 11, 2018 | Ninepoint Medical Inc. NvisionVLE Low-Profile Optical Probe; Catalog Numbers: 95501-LP and 95501-LP-5; UDI Information: (01)00859591006188(17)180531(10)005196), (01)00859591006188(17)180731(10)005251), (01)00859591006188 Terminated |
NQQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.