The following data is part of a premarket notification filed by Terumo Corporation with the FDA for Navicross 0.018.
| Device ID | K173799 |
| 510k Number | K173799 |
| Device Name: | NaviCross 0.018 |
| Classification | Catheter, Percutaneous |
| Applicant | Terumo Corporation 44-1, 2-Chome, Hatagaya Shibuya-ku,, JP 151-0072 |
| Contact | Yuko Watanabe |
| Correspondent | Yuko Watanabe Terumo Medical Corporation 265 Davidson Ave., Suite 320 Somerset, NJ 08873 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-14 |
| Decision Date | 2018-03-29 |
| Summary: | summary |