The following data is part of a premarket notification filed by Nitiloop Ltd. with the FDA for Novacross Microcatheter.
| Device ID | K160389 |
| 510k Number | K160389 |
| Device Name: | NovaCross Microcatheter |
| Classification | Catheter, Percutaneous |
| Applicant | Nitiloop Ltd. 4 Haomanut Street Netanya, IL 4250438 |
| Contact | Chanan Schneider |
| Correspondent | Michael Daniel Daniel & Daniel Consulting, LLC 340 Jones Lane Gardnerville, NV 89460 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-11 |
| Decision Date | 2016-03-11 |
| Summary: | summary |