The following data is part of a premarket notification filed by Terumo Medical Corporation with the FDA for Radifocus Glidewire Advantage, Radifocus Glidewire Advantage.
| Device ID | K122590 |
| 510k Number | K122590 |
| Device Name: | RADIFOCUS GLIDEWIRE ADVANTAGE, RADIFOCUS GLIDEWIRE ADVANTAGE |
| Classification | Wire, Guide, Catheter |
| Applicant | Terumo Medical Corporation 265 DAVIDSON AVE, STE 320 Somerset, NJ 08873 |
| Contact | Stacy A Kluesner, Ms, Rac |
| Correspondent | Stacy A Kluesner, Ms, Rac Terumo Medical Corporation 265 DAVIDSON AVE, STE 320 Somerset, NJ 08873 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-24 |
| Decision Date | 2013-03-01 |
| Summary: | summary |