Atlas FDA

MOF

42 FDA 510(k) clearances · Product code

94 daysmedian time to decision
238 days90th percentile
42clearances measured

FDA profile

Official device name
Guide, Wire, Catheter, Neurovasculature
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1330
Medical specialty
Cardiovascular
Flags
Third-party review eligible
Adverse events (MAUDE)
2021: 39 · 2022: 92 · 2023: 91 · 2024: 95 · 2025: 137 · 2026: 131
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Aristotle Mini Guidewire (K260223)Scientia Vascular, Inc.2026-08-06
Drivewire 35 Guidewire (K254006)Rapid Medical Ltd.2026-07-17
Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire (K253579)Scientia Vascular, Inc.2026-04-29
Zenith Micro Guidewire (K252317)Suzhou Zenith Vascular SciTech Limited2026-04-16
Willow 24 Guidewire (K260537)Arbor Endovascular, LLC2026-03-19
DCwire Micro-guidewire (K252122)Shanghai Achieva Medical Suzhou Co., Ltd.2026-03-16
Willow 18 Guidewire (K260130)Arbor Endovascular, LLC2026-02-13
CHIKAI Nexus petit (K252011)Asahi Intecc Co., Ltd.2026-02-02
0.014” Willow Guidewire (K253168)Arbor Endovascular, LLC2025-11-26
X-Wire Guidewire (K244061)Imperative Care, Inc.2025-08-26
0.014” Willow Guidewire (K243756)Arbor Endovascular, LLC2025-07-17
CHIKAI Nexus 014 (K243383)Asahi Intecc Co., Ltd.2025-04-21
Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire; Aristotle Colossus Guidewire (K243938)Scientia Vascular, Inc.2025-04-01
Synxess Neurovascular Guidewire (K240871)Enlight Medical Technologies (Shenzhen) Co., Ltd.2024-11-18
Drivewire 24 Guidewire (K233791)Rapid-Medical , Ltd.2024-07-11
Aristotle 18 Guidewire; Aristotle 24 Guidewire (K231954)Scientia Vascular, Inc.2023-08-01
SmartGUIDE deflectable hydrophilic guidewire (K222690)Artiria Medical SA2023-04-24
Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 Guidewire; Zoom Wire 14 Guidewire (K220398)Scientia Vascular, LLC2023-03-10
Aristotle Colossus Guidewire (K222437)Scientia Vascular, Inc.2023-01-26
RADIFOCUS Torque Device (K220934)Terumo Medical Products (Hangzhou) Co., Ltd.2022-06-29
Columbus Guidewire (K200374)Rapid-Medical , Ltd.2020-12-14
Synchro SELECT Guidewire (K202522)Stryker Neurovascular2020-09-25
Traxcess 7 Mini Guidewire (K201487)MicroVention, Inc.2020-07-02
Traxcess 14 SELECT Guidewire (K200547)MicroVention, Inc.2020-04-16
ASAHI Neurovascular Guide Wire CHIKAI X 014 soft (K191714)Asahi Intecc Co., Ltd.2019-07-26
Synchro2 Support Guidewire (K190843)Stryker2019-05-01
Aristotle 18 Guidewire, 200cm, Soft Profile ; Aristotle 18 Guidewire, 200cm, Standard Profile ; Aristotle 18 Guidewire, 200cm, Support Profile (K183608)Scientia Vascular, LLC2019-03-22
ASAHI Neurovascular Guide Wire, ASAHI CHIKAI X 010 (K183070)Asahi Intecc Co., Ltd.2019-01-29
HYBRID Guidewire (K182337)Balt USA, LLC2018-10-04
Volo 14 Guidewire, 200cm, Soft Profile, Volo 14 Guidewire, 200cm, Standard Profile, Volo 14 Guidewire, 300cm, Soft Profile, Volo 14 Guidewire, 300cm, Standard Profile (K181828)Scientia Vascular, LLC2018-08-07
ASAHI Neurovasulature Guide Wire: ASAHI CHIKAI black 18 soft tip (K171613)Asahi Intecc Co., Ltd.2017-07-01
Traxcess 7 Mini XSoft Guidewire (K163154)MicroVention, Inc.2016-12-09
ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 14 soft tip (K161912)Asahi Intecc Co., Ltd.2016-10-14
Traxcess .007 Mini Guidewire (K161803)MicroVention, Inc.2016-09-30
ASAHI CHIKAI Neurovascular Guide Wire (Round Curve) (K160659)Asahi Intecc Co., Ltd.2016-04-07
Traxcess Pro 14 Guidewire (K153053)MicroVention, Inc.2015-12-29
Viradius Neurowire (K151825)Mivi Neuroscience, Inc.2015-11-16
ASAHI NEUROVASCULAR GUIDE WIRE ASAHI CHIKAI 008, ASAHI NEUROVASCULAR GUIDE WIRE ASAHI CHIKAI BLACK, ASAHI NEUROVASCULAR (K141751)Asahi Intecc Co., Ltd.2015-01-30
TRAXCESS 14 GUIDEWIRE (K133725)MicroVention, Inc.2014-07-31
AGILITY 10 STANDARD & SOFT 0.01IN. X 195CM, AGILITY 14 STANDARD & SOFT 0.014IN X 205CM & XL 350CM, AGILITY 16 STANDARD & (K133625)Codman & Shurtleff, Inc.2014-02-24
ASAHI CHIKAI 10 NEUROVASCULAR GUIDE WIRE (K112979)Asahi Intecc Co., Ltd.2011-12-01
ASAHI CHIKAI NEUROVASCULAR GUIDE WIRE (K110584)Asahi Intecc Co., Ltd.2011-08-22

Track MOF automatically

Every clearance here is in the API, with alerts when new ones post.