The following data is part of a premarket notification filed by Nitiloop Ltd. with the FDA for Novacross Microcatheter.
| Device ID | K143608 |
| 510k Number | K143608 |
| Device Name: | NovaCross Microcatheter |
| Classification | Catheter, Percutaneous |
| Applicant | Nitiloop Ltd. 8 Hamada St. P.O.Box 12892 Herzliya, IL 46733 |
| Contact | Michael A Daniel |
| Correspondent | Michael A Daniel Daniel & Daniel Consulting 340 Jones Lane Gardnerville, NV 89460 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-19 |
| Decision Date | 2015-05-04 |
| Summary: | summary |