The following data is part of a premarket notification filed by Ashitaka Factory Of Terumo Coporation with the FDA for Radifocus Glidewire Advantage Track.
| Device ID | K163004 |
| 510k Number | K163004 |
| Device Name: | Radifocus Glidewire Advantage Track |
| Classification | Wire, Guide, Catheter |
| Applicant | Ashitaka Factory Of Terumo Coporation 150 Maimaigi-cho Fujinomiya Shizuoka, JP 418-0015 |
| Contact | Dina Justice |
| Correspondent | Liang Lu Terumo Medical Corporation 950 Elkton Blvd Elkton, MD 21921 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-28 |
| Decision Date | 2017-01-30 |
| Summary: | summary |