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 |