The following data is part of a premarket notification filed by Asahi Intecc Co., Ltd with the FDA for Branchor Balloon Guide Catheter.
| Device ID | K221951 |
| 510k Number | K221951 |
| Device Name: | Branchor Balloon Guide Catheter |
| Classification | Catheter, Percutaneous, Neurovasculature |
| Applicant | Asahi Intecc Co., Ltd 3-100 Akatsuki-cho Seto, JP 489-0071 |
| Contact | Katsuhiko Fujimura |
| Correspondent | Cynthia Valenzuela Asahi Intecc USA, Inc. 3002 Dow Avenue, Suite 212 Tustin, CA 92780 |
| Product Code | QJP |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-07-05 |
| Decision Date | 2022-10-11 |