The following data is part of a premarket notification filed by Terumo Medical Corporation with the FDA for Radifocus Glidewire Endoscopic Wire.
| Device ID | K151471 |
| 510k Number | K151471 |
| Device Name: | Radifocus Glidewire Endoscopic Wire |
| Classification | Endoscopic Guidewire, Gastroenterology-urology |
| Applicant | Terumo Medical Corporation 265 Davidson Ave, Suite 320 Somerset, NJ 08873 |
| Contact | Phebe Varghese |
| Correspondent | Phebe Varghese Terumo Medical Corporation 265 Davidson Ave, Suite 320 Somerset, NJ 08873 |
| Product Code | OCY |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-01 |
| Decision Date | 2015-09-17 |
| Summary: | summary |