The following data is part of a premarket notification filed by Ninepoint Medical, Inc with the FDA for Nvision Vle Imaging System Nvision Vle Catheter.
| Device ID | K121195 |
| 510k Number | K121195 |
| Device Name: | NVISION VLE IMAGING SYSTEM NVISION VLE CATHETER |
| Classification | System, Imaging, Optical Coherence Tomography (oct) |
| Applicant | NINEPOINT MEDICAL, INC 1171 BARROIHET AVENUE Hillsborough, CA 94010 |
| Contact | Cindy Domecus |
| Correspondent | Cindy Domecus NINEPOINT MEDICAL, INC 1171 BARROIHET AVENUE Hillsborough, CA 94010 |
| Product Code | NQQ |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-19 |
| Decision Date | 2012-07-25 |
| Summary: | summary |