The following data is part of a premarket notification filed by Nitiloop Ltd. with the FDA for Novacross Cto Microcatheter.
| Device ID | K193322 |
| 510k Number | K193322 |
| Device Name: | NovaCross CTO Microcatheter |
| Classification | Catheter, Percutaneous |
| Applicant | Nitiloop Ltd. 1st Tidar Street Pardes Hanna, IL 3701000 |
| Contact | Amir Pansky |
| Correspondent | Wanda Carpinella Boston Biomedical Associates, LLC One Crowley Drive, Suite 216 Marlborough, MA 01752 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-02 |
| Decision Date | 2020-04-02 |