The following data is part of a premarket notification filed by Asahi Intecc Co., Ltd. with the FDA for Asahi Precious Guide Catheter.
| Device ID | K061601 |
| 510k Number | K061601 |
| Device Name: | ASAHI PRECIOUS GUIDE CATHETER |
| Classification | Catheter, Percutaneous |
| 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 | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-08 |
| Decision Date | 2006-11-17 |
| Summary: | summary |