The following data is part of a premarket notification filed by Terumo Medical Corp. with the FDA for Radifocus Glidewire Advantage.
| Device ID | K063372 |
| 510k Number | K063372 |
| Device Name: | RADIFOCUS GLIDEWIRE ADVANTAGE |
| Classification | Wire, Guide, Catheter |
| Applicant | TERUMO MEDICAL CORP. 950 Elkton Blvd. Elkton, MD 21921 |
| Contact | Mark Unterreiner |
| Correspondent | Mark Unterreiner TERUMO MEDICAL CORP. 950 Elkton Blvd. Elkton, MD 21921 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-08 |
| Decision Date | 2007-01-19 |
| Summary: | summary |