FDA 510(k) Applications Submitted by YASUYUKI KAWAHARA
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K190176 |
02/01/2019 |
MINAMO |
Asahi Intecc Co., Ltd. |
| K180784 |
03/26/2018 |
ASAHI PTCA Guide Wire ASAHI Gladius Mongo 14, ASAHI Gladius Mongo 14 ES |
ASAHI INTECC CO., LTD. |
| K171613 |
06/01/2017 |
ASAHI Neurovasulature Guide Wire: ASAHI CHIKAI black 18 soft tip |
Asahi Intecc Co., Ltd. |
| K191464 |
06/03/2019 |
Asahi PTCA Guide Wire Asahi SION Series |
Asahi Intecc Co., LTD. |
| K191714 |
06/26/2019 |
ASAHI Neurovascular Guide Wire CHIKAI X 014 soft |
Asahi Intecc Co., Ltd. |
| K171933 |
06/28/2017 |
ASAHI PTCA Guide Wires, ASAHI Corsair Microcatheter, ASAHI Corsair Pro Microcatheter |
Asahi Intecc Co., Ltd. |
| K161912 |
07/12/2016 |
ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 14 soft tip |
ASAHI INTECC CO., LTD. |
| K202252 |
08/10/2020 |
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), |
Asahi Intecc Co., Ltd. |
| K182420 |
09/05/2018 |
ASAHI Corsair Pro XS |
Asahi Intecc Co., Ltd. |
| K192599 |
09/20/2019 |
ASAHI PTCA Guide Wire ASAHI Gaia Next |
Asahi Intecc Co., Ltd. |
| K182844 |
10/09/2018 |
ASAHI SASUKE |
Asahi Intecc Co., Ltd. |
| K162842 |
10/11/2016 |
ASAHI PTCA Guide Wire ASAHI SUOH 03 |
ASAHI INTECC CO., LTD. |
| K173277 |
10/13/2017 |
ASAHI PTCA Guide Wire ASAHI SION black |
Asahi Intecc Co., Ltd. |
| K183062 |
11/05/2018 |
ASAHI Silverway |
Asahi Intecc Co., LTD. |
| K183070 |
11/05/2018 |
ASAHI Neurovascular Guide Wire, ASAHI CHIKAI X 010 |
Asahi Intecc Co., Ltd. |
| K163426 |
12/06/2016 |
ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire Extension |
ASAHI INTECC CO., LTD. |
| K203723 |
12/21/2020 |
Branchor Balloon Guide Catheter |
Asahi Intecc Co., Ltd |
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