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 |