FDA 510(k) Applications Submitted by Asahi Intecc Co., LTD.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K141339 |
05/21/2014 |
ASAHI RG3 GUIDEWIRE/ASAHI RG3 SOFT GUIDEWIRE |
ASAHI INTECC CO., LTD. |
| K141981 |
07/21/2014 |
ASAHI FUBUKI 043 / ASAHI FUBUKI |
ASAHI INTECC CO., LTD. |
| K133865 |
12/19/2013 |
ASAHI GAIA FIRST, SECOND, THIRD |
ASAHI INTECC CO., LTD. |
| K160659 |
03/08/2016 |
ASAHI CHIKAI Neurovascular Guide Wire (Round Curve) |
ASAHI INTECC CO., LTD. |
| K161126 |
04/21/2016 |
ASAHI Corsair Pro |
ASAHI INTECC CO., LTD. |
| K161362 |
05/16/2016 |
ASAHI Corsair Armet |
Asahi Intecc Co., Ltd. |
| K251240 |
04/22/2025 |
Branchor X Balloon Guide Catheter |
Asahi Intecc Co., Ltd. |
| K241158 |
04/26/2024 |
ASAHI Veloute; ASAHI Veloute C3; ASAHI Tellus; ASAHI Tellus C3 |
Asahi Intecc Co., Ltd. |
| K251560 |
05/21/2025 |
FUBUKI XF-R Neurovascular Long Sheath |
Asahi Intecc Co., Ltd. |
| K230377 |
02/13/2023 |
CROSSLEAD Penetration Peripheral Guide Wire |
ASAHI INTECC Co., Ltd. |
| K241510 |
05/29/2024 |
CROSSLEAD Tracker |
ASAHI INTECC CO., LTD. |
| K241702 |
06/13/2024 |
CROSSLEAD 0.014inch |
Asahi Intecc Co., Ltd. |
| K241801 |
06/21/2024 |
Tornus ES |
ASAHI Intecc Co., Ltd. |
| K241962 |
07/03/2024 |
Crossloop |
Asahi Intecc Co., Ltd. |
| K242597 |
08/30/2024 |
CROSSLEAD 0.018inch |
Asahi Intecc Co., Ltd. |
| K243383 |
10/31/2024 |
CHIKAI Nexus 014 |
ASAHI INTECC CO., LTD. |
| K243733 |
12/04/2024 |
SION blue PLUS |
ASAHI INTECC CO., LTD. |
| K141751 |
06/30/2014 |
ASAHI NEUROVASCULAR GUIDE WIRE ASAHI CHIKAI 008, ASAHI NEUROVASCULAR GUIDE WIRE ASAHI CHIKAI BLACK, ASAHI NEUROVASCULAR |
ASAHI INTECC CO., LTD. |
| K211898 |
06/21/2021 |
ASAHI PCI Guide Wire ASAHI CONFIANZA PRO 8-20 |
Asahi Intecc Co., Ltd. |
| K213315 |
10/04/2021 |
CROSSLEAD Peripheral Guide Wire |
Asahi Intecc Co., LTD. |
| K213589 |
11/12/2021 |
FUBUKI XF Neurovascular Long Sheath |
Asahi Intecc Co., Ltd. |
| K213868 |
12/10/2021 |
ASAHI Gladius Mongo18 PV ES |
Asahi Intecc Co., LTD. |
| 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. |
| K192782 |
09/30/2019 |
ASAHI CROSSWALK Peripheral Support Catheter |
Asahi Intecc Co., Ltd. |
| K100578 |
03/01/2010 |
ASAHI SION PTCA GUIDE WIRE MODEL AHW14R001S & AHW14R301S |
ASAHI INTECC CO., LTD. |
| K110584 |
03/01/2011 |
ASAHI CHIKAI NEUROVASCULAR GUIDE WIRE |
ASAHI INTECC CO., LTD. |
| K060745 |
03/20/2006 |
ASAHI TORNUS SUPPORT CATHETER WITH TORQUE DEVICE ACCESSORY |
ASAHI INTECC CO., LTD. |
| K070945 |
04/04/2007 |
ASAHI PTCA GUIDE WIRE |
ASAHI INTECC CO., LTD. |
| K091188 |
04/23/2009 |
ASAHI ZENYTEEX GUIDING CATHETER |
ASAHI INTECC CO., LTD. |
| K041531 |
06/08/2004 |
ASAHI PTCA GUIDE WIRE CONFIANZA PRO |
ASAHI INTECC CO., LTD. |
| K061601 |
06/08/2006 |
ASAHI PRECIOUS GUIDE CATHETER |
ASAHI INTECC CO., LTD. |
| K051561 |
06/13/2005 |
ASAHI ANGIOGRAPHIC CATHETER |
ASAHI INTECC CO., LTD. |
| K071721 |
06/25/2007 |
ASAHI ASTATO 30 PERIPHERAL GUIDE WIRE, MODELS - PAGH18M071, PAGH18M371 |
ASAHI INTECC CO., LTD. |
| K051772 |
06/30/2005 |
ASAHI TORNUS SUPPORT CATHETER |
ASAHI INTECC CO., LTD. |
| K061984 |
07/13/2006 |
TREASURE |
ASAHI INTECC CO., LTD. |
| K101986 |
07/14/2010 |
ASAHI ULTIMATEBROS 3 PTCA GUIDE WIRE |
ASAHI INTECC CO., LTD. |
| K101985 |
07/14/2010 |
ASAHI GUIDE WIRE EXTENSION 165CM |
ASAHI INTECC CO., LTD. |
| K052022 |
07/26/2005 |
ASAHI PTCA GUIDE WIRE FIELDER |
ASAHI INTECC CO., LTD. |
| K062186 |
07/31/2006 |
ASAHI PTCA GUIDE WIRE, FIELDER J, MODEL AGP140000J, AGP140300J |
ASAHI INTECC CO., LTD. |
| K122469 |
08/13/2012 |
ASAHI PTCA GUIDE WIRE ASAHI SION 180CMJ ASAHI PTCA GUIDE WIRE ASAHI SION 300CMJ |
ASAHI INTECC CO., LTD. |
| K122468 |
08/13/2012 |
ASAHI PTCA GUIDE WIRE ASAHI SION BLUE 180CM ASAHI PTCA GUIDE WIRE ASAHI SION BLUE 3300CM ASAHI PTCA GUIDE WIRE ASAHI SIO |
ASAHI INTECC CO., LTD. |
| K132556 |
08/14/2013 |
SHEATHLESS EAUCATH CORONARY GUIDE CATHETER |
ASAHI INTECC CO., LTD. |
| K072316 |
08/17/2007 |
PRECIOUS PLUS GUIDE CATHETER |
ASAHI INTECC CO., LTD. |
| K032615 |
08/25/2003 |
ASAHI PTCA CATHETER GUIDE WIRES, MODELS AGH147000 AND AGH147300 |
ASAHI INTECC CO., LTD. |
| K052339 |
08/26/2005 |
ASAHI PTCA GUIDE WIRE |
ASAHI INTECC CO., LTD. |
| K072431 |
08/29/2007 |
ASAHI PTCA GUIDE WIRE, X-TREME |
ASAHI INTECC CO., LTD. |
| K072705 |
09/24/2007 |
ASAHI PTCA GUIDE WIRE, FIELDER FC J, MODELS: AGP140001J, AGP140301J |
ASAHI INTECC CO., LTD. |
| K062885 |
09/26/2006 |
STRIDE MICROCATHETER |
ASAHI INTECC CO., LTD. |
| K112979 |
10/06/2011 |
ASAHI CHIKAI 10 NEUROVASCULAR GUIDE WIRE |
ASAHI INTECC CO., LTD. |
| K103057 |
10/15/2010 |
ASAHI ASTATO XS 20 PERIPHERAL GUIDE WIRE |
ASAHI INTECC CO., LTD. |
| K083127 |
10/21/2008 |
ASAHI CORSAIR MICROCATHETER |
ASAHI INTECC CO., LTD. |
| K083146 |
10/23/2008 |
ASAHI REGALIA XS 1.0 PERIPHERAL GUIDE WIRE, MODELS PAGP 140000 & PAGP 1403000 |
ASAHI INTECC CO., LTD. |
| K083145 |
10/23/2008 |
ASAHI GUIDE WIRE EXTENSION, MODEL AG149000 |
ASAHI INTECC CO., LTD. |
| K043422 |
12/13/2004 |
ASAHI PTCA GUIDE WIRE, J SHAPE SERIES |
ASAHI INTECC CO., LTD. |
| K113716 |
12/19/2011 |
ASAHI CHIKAI V PERIPHERAL VASCULAR GUIDE WIRE |
ASAHI INTECC CO., LTD. |
| K063819 |
12/26/2006 |
ASAHI PTCA GUIDE WIRE, FIELDER FC |
ASAHI INTECC CO., LTD. |
| K083904 |
12/29/2008 |
ASAHI SUOH PTCA GUIDE WIRE |
ASAHI INTECC CO., LTD. |
| K150445 |
02/20/2015 |
ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV) |
ASAHI INTECC CO., LTD. |
| K151103 |
04/24/2015 |
ASAHI Corsair Microcatheter |
ASAHI INTECC CO., LTD. |
| K152249 |
08/10/2015 |
ASAHI Corsair Armet |
ASAHI INTECC CO., LTD. |
| K152447 |
08/27/2015 |
ASAHI Caravel |
ASAHI INTECC CO., LTD. |
| K153106 |
10/27/2015 |
ASAHI Fielder XT-A, ASAHI Fielder XT-R |
ASAHI INTECC CO., LTD. |
| K153443 |
11/27/2015 |
ASAHI Astato XS 40 |
ASAHI INTECC CO., LTD. |
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