FDA 510(k) Applications for Medical Device Product Code "MOF"
(Guide, Wire, Catheter, Neurovasculature)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K222690 | Artiria Medical SA | SmartGUIDE deflectable hydrophilic guidewire | 04/24/2023 |
| K112979 | ASAHI INTECC CO., LTD. | ASAHI CHIKAI 10 NEUROVASCULAR GUIDE WIRE | 12/01/2011 |
| K110584 | ASAHI INTECC CO., LTD. | ASAHI CHIKAI NEUROVASCULAR GUIDE WIRE | 08/22/2011 |
| K160659 | ASAHI INTECC CO., LTD. | ASAHI CHIKAI Neurovascular Guide Wire (Round Curve) | 04/07/2016 |
| K141751 | ASAHI INTECC CO., LTD. | ASAHI NEUROVASCULAR GUIDE WIRE ASAHI CHIKAI 008, ASAHI NEUROVASCULAR GUIDE WIRE ASAHI CHIKAI BLACK, ASAHI NEUROVASCULAR | 01/30/2015 |
| K191714 | Asahi Intecc Co., Ltd. | ASAHI Neurovascular Guide Wire CHIKAI X 014 soft | 07/26/2019 |
| K183070 | Asahi Intecc Co., Ltd. | ASAHI Neurovascular Guide Wire, ASAHI CHIKAI X 010 | 01/29/2019 |
| K161912 | ASAHI INTECC CO., LTD. | ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 14 soft tip | 10/14/2016 |
| K171613 | Asahi Intecc Co., Ltd. | ASAHI Neurovasulature Guide Wire: ASAHI CHIKAI black 18 soft tip | 07/01/2017 |
| K182337 | Balt USA, LLC | HYBRID Guidewire | 10/04/2018 |
| K133625 | Codman & Shurtleff, Inc. | AGILITY 10 STANDARD & SOFT 0.01IN. X 195CM, AGILITY 14 STANDARD & SOFT 0.014IN X 205CM & XL 350CM, AGILITY 16 STANDARD & | 02/24/2014 |
| K201487 | Micro Vention Inc. | Traxcess 7 Mini Guidewire | 07/02/2020 |
| K200547 | MicroVention Inc. | Traxcess 14 SELECT Guidewire | 04/16/2020 |
| K161803 | MICROVENTION, INC. | Traxcess .007 Mini Guidewire | 09/30/2016 |
| K133725 | MICROVENTION, INC. | TRAXCESS 14 GUIDEWIRE | 07/31/2014 |
| K163154 | MicroVention, Inc. | Traxcess 7 Mini XSoft Guidewire | 12/09/2016 |
| K153053 | MICROVENTION, INC. | Traxcess Pro 14 Guidewire | 12/29/2015 |
| K151825 | MIVI NEUROSCIENCE, INC. | Viradius Neurowire | 11/16/2015 |
| K200374 | Rapid-Medical Ltd. | Columbus Guidewire | 12/14/2020 |
| K222437 | Scientia Vascular Inc | Aristotle Colossus Guidewire | 01/26/2023 |
| K183608 | Scientia Vascular LLC | Aristotle 18 Guidewire, 200cm, Soft Profile ; Aristotle 18 Guidewire, 200cm, Standard Profile ; Aristotle 18 Guidewire, 200cm, Support Profile | 03/22/2019 |
| K181828 | Scientia Vascular LLC | Volo 14 Guidewire, 200cm, Soft Profile, Volo 14 Guidewire, 200cm, Standard Profile, Volo 14 Guidewire, 300cm, Soft Profile, Volo 14 Guidewire, 300cm, Standard Profile | 08/07/2018 |
| K231954 | Scientia Vascular, Inc. | Aristotle 18 Guidewire; Aristotle 24 Guidewire | 08/01/2023 |
| K220398 | Scientia Vascular, LLC | Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 Guidewire; Zoom Wire 14 Guidewire | 03/10/2023 |
| K190843 | Stryker | Synchro2 Support Guidewire | 05/01/2019 |
| K202522 | STRYKER NEUROVASCULAR | Synchro SELECT Guidewire | 09/25/2020 |
| K220934 | Terumo Medical Products (Hangzhou) Co., Ltd. | RADIFOCUS Torque Device | 06/29/2022 |
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