The following data is part of a premarket notification filed by Asahi Intecc Co., Ltd. with the FDA for Asahi Crosswalk Peripheral Support Catheter.
| Device ID | K192782 |
| 510k Number | K192782 |
| Device Name: | ASAHI CROSSWALK Peripheral Support Catheter |
| Classification | Catheter, Percutaneous |
| Applicant | Asahi Intecc Co., Ltd. 3-100 Akatsuki-cho Seto, JP 489-0071 |
| Contact | Yasuyuki Kawuhara |
| Correspondent | Cynthia Valenzuela Asahi Intecc USA, Inc. 3002 Dow Avenue, Suite 212 Tustin, CA 92780 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-30 |
| Decision Date | 2019-11-29 |
| Summary: | summary |