The following data is part of a premarket notification filed by Ashitaka Factory Of Terumo Corp. with the FDA for Radifocus Optitorque Angiographic Catheter.
Device ID | K150232 |
510k Number | K150232 |
Device Name: | Radifocus Optitorque Angiographic Catheter |
Classification | Catheter, Intravascular, Diagnostic |
Applicant | ASHITAKA FACTORY OF TERUMO CORP. 150 MAIMAIGI-CHO Fujinomiya, Shizuoka, JP 418-0015 |
Contact | Monika Mcdole-russell |
Correspondent | Monika Mcdole-russell TERUMO MEDICAL CORP. 265 Davidson Ave., Suite 320 Somerset, NJ 08873 |
Product Code | DQO |
CFR Regulation Number | 870.1200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-02-02 |
Decision Date | 2015-10-19 |
Summary: | summary |