The following data is part of a premarket notification filed by Asahi Intecc Co., Ltd. with the FDA for Asahi Angiographic Catheter.
| Device ID | K051561 |
| 510k Number | K051561 |
| Device Name: | ASAHI ANGIOGRAPHIC CATHETER |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | ASAHI INTECC CO., LTD. 1301 DOVE STREET, SUITE #350 Newport Beach, CA 92660 |
| Contact | Yoshi Terai |
| Correspondent | Yoshi Terai ASAHI INTECC CO., LTD. 1301 DOVE STREET, SUITE #350 Newport Beach, CA 92660 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-13 |
| Decision Date | 2005-11-02 |
| Summary: | summary |