The following data is part of a premarket notification filed by Asahi Intecc Co., Ltd. with the FDA for Asahi Corsair Armet 18 Microcatheter (model: Csar060-18n), Asahi Corsair Armet 18 Microcatheter (model: Csar090-18n), Asahi Corsair Armet 18 Microcatheter (model: Csar110-18n), Asahi Corsair Armet 18 Microcatheter (model: Csar135-18n),.
| Device ID | K202252 |
| 510k Number | K202252 |
| Device Name: | ASAHI Corsair Armet 18 Microcatheter (Model: CSAR060-18N), ASAHI Corsair Armet 18 Microcatheter (Model: CSAR090-18N), ASAHI Corsair Armet 18 Microcatheter (Model: CSAR110-18N), ASAHI Corsair Armet 18 Microcatheter (Model: CSAR135-18N), |
| Classification | Catheter, Percutaneous |
| Applicant | Asahi Intecc Co., Ltd. 3-100 Akatsuki-Cho Seto, JP 489-0071 |
| Contact | Yasuyuki Kawahara |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-10 |
| Decision Date | 2020-09-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04547327134040 | K202252 | 000 |
| 04547327134033 | K202252 | 000 |
| 04547327134026 | K202252 | 000 |
| 04547327134019 | K202252 | 000 |