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 |