The following data is part of a premarket notification filed by Ninepoint Medical, Inc with the FDA for Nvisionvle Imaging Console, Nvisionvle Marking Probe, 20mm Balloon, Nvisionvle Marking Probe, 17mm Balloon,nvisionvle Marking Probe, 14mm Balloon, Nvisionvle Inflation System.
| Device ID | K153479 |
| 510k Number | K153479 |
| Device Name: | NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm Balloon, NvisionVLE Marking Probe, 17mm Balloon,NvisionVLE Marking Probe, 14mm Balloon, NvisionVLE Inflation System |
| Classification | System, Imaging, Optical Coherence Tomography (oct) |
| Applicant | NINEPOINT MEDICAL, INC 12 OAK PARK DRIVE Bedford, MA 01730 |
| Contact | Eman Namati |
| Correspondent | Eman Namati NINEPOINT MEDICAL, INC 12 OAK PARK DRIVE Bedford, MA 01730 |
| Product Code | NQQ |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-02 |
| Decision Date | 2016-02-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00859591006225 | K153479 | 000 |
| 00859591006065 | K153479 | 000 |
| 00859591006072 | K153479 | 000 |
| 00859591006102 | K153479 | 000 |
| 00859591006119 | K153479 | 000 |
| 00859591006126 | K153479 | 000 |
| 00859591006133 | K153479 | 000 |
| 00859591006140 | K153479 | 000 |
| 00859591006218 | K153479 | 000 |
| 00859591006058 | K153479 | 000 |