The following data is part of a premarket notification filed by Ashitaka Factory Of Terumo Corp. with the FDA for Radifocus Glidewire.
| Device ID | K152740 |
| 510k Number | K152740 |
| Device Name: | Radifocus Glidewire |
| Classification | Wire, Guide, Catheter |
| Applicant | ASHITAKA FACTORY OF TERUMO CORP. 150 MAIMAIGI-CHO Fujinomiya Shizuoka, JP 418-0015 |
| Contact | Phebe Varghese |
| Correspondent | Phebe Varghese TERUMO MEDICAL CORPORATION 265 DAVIDSON AVENUE, 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 | 2015-09-23 |
| Decision Date | 2015-11-16 |
| Summary: | summary |