The following data is part of a premarket notification filed by Terumo Corporation with the FDA for Glidewire Gt.
| Device ID | K170417 |
| 510k Number | K170417 |
| Device Name: | Glidewire GT |
| Classification | Wire, Guide, Catheter |
| Applicant | Terumo Corporation 44-1, 2-Chome, Hatagaya Shibuya-ku,, JP 151-0072 |
| Contact | Monika Mcdole-russell |
| Correspondent | Monika Mcdole-russell Terumo Medical Corporation 265 Davidson Ave., Suite 320 Somerset, NJ 08873 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-10 |
| Decision Date | 2017-09-15 |
| Summary: | summary |