Guide, Wire, Catheter, Neurovasculature

FDA product code MOF · 40 cleared devices

Class 2 Cardiovascular

Regulation: 21 CFR 870.1330
Review panel: NE
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 2011-08-22 – 2026-09-16

MOF 2026-09-16

Aristotle 65 Macrowire

Applicant Scientia Vascular

K number K254181

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MOF 2026-08-27

35 Helix Guidewire

Applicant Piraeus Medical, Inc.

K number K260751

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MOF 2026-08-14

Willow 12 Guidewire

Applicant Arbor Endovascular, LLC

K number K262424

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MOF 2026-08-06

Aristotle Mini Guidewire

Applicant Scientia Vascular, Inc.

K number K260223

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MOF 2026-07-17

Drivewire 35 Guidewire

Applicant Rapid Medical Ltd.

K number K254006

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MOF 2026-04-29

Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire

Applicant Scientia Vascular, Inc.

K number K253579

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MOF 2026-04-16

Zenith Micro Guidewire

Applicant Suzhou Zenith Vascular SciTech Limited

K number K252317

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MOF 2026-03-19

Willow 24 Guidewire

Applicant Arbor Endovascular, LLC

K number K260537

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MOF 2026-03-16

DCwire Micro-guidewire

Applicant Shanghai Achieva Medical Suzhou Co., Ltd.

K number K252122

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MOF 2026-02-13

Willow 18 Guidewire

Applicant Arbor Endovascular, LLC

K number K260130

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MOF 2026-02-02

CHIKAI Nexus petit

Applicant Asahi Intecc Co., Ltd.

K number K252011

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MOF 2025-11-26

0.014” Willow Guidewire

Applicant Arbor Endovascular, LLC

K number K253168

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MOF 2025-08-26

X-Wire Guidewire

Applicant Imperative Care, Inc.

K number K244061

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MOF 2025-07-17

0.014” Willow Guidewire

Applicant Arbor Endovascular, LLC

K number K243756

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MOF 2025-04-21

CHIKAI Nexus 014

Applicant Asahi Intecc Co., Ltd.

K number K243383

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MOF 2025-04-01

Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire; Aristotle Colossus Guidewire

Applicant Scientia Vascular, Inc.

K number K243938

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MOF 2024-11-18

Synxess Neurovascular Guidewire

Applicant Enlight Medical Technologies (Shenzhen) Co., Ltd.

K number K240871

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MOF 2024-07-11

Drivewire 24 Guidewire

Applicant Rapid-Medical , Ltd.

K number K233791

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MOF 2023-08-01

Aristotle 18 Guidewire; Aristotle 24 Guidewire

Applicant Scientia Vascular, Inc.

K number K231954

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MOF 2023-04-24

SmartGUIDE deflectable hydrophilic guidewire

Applicant Artiria Medical SA

K number K222690

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MOF 2023-03-10

Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 Guidewire; Zoom Wire 14 Guidewire

Applicant Scientia Vascular, LLC

K number K220398

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MOF 2023-01-26

Aristotle Colossus Guidewire

Applicant Scientia Vascular, Inc.

K number K222437

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MOF 2022-06-29

RADIFOCUS Torque Device

Applicant Terumo Medical Products (Hangzhou) Co., Ltd.

K number K220934

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MOF 2020-12-14

Columbus Guidewire

Applicant Rapid-Medical , Ltd.

K number K200374

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MOF 2020-09-25

Synchro SELECT Guidewire

Applicant Stryker Neurovascular

K number K202522

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MOF 2020-07-02

Traxcess 7 Mini Guidewire

Applicant MicroVention, Inc.

K number K201487

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MOF 2020-04-16

Traxcess 14 SELECT Guidewire

Applicant MicroVention, Inc.

K number K200547

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MOF 2019-07-26

ASAHI Neurovascular Guide Wire CHIKAI X 014 soft

Applicant Asahi Intecc Co., Ltd.

K number K191714

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MOF 2019-05-01

Synchro2 Support Guidewire

Applicant Stryker

K number K190843

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MOF 2019-03-22

Aristotle 18 Guidewire, 200cm, Soft Profile ; Aristotle 18 Guidewire, 200cm, Standard Profile ; Aristotle 18 Guidewire, 200cm, Support Profile

Applicant Scientia Vascular, LLC

K number K183608

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MOF 2019-01-29

ASAHI Neurovascular Guide Wire, ASAHI CHIKAI X 010

Applicant Asahi Intecc Co., Ltd.

K number K183070

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MOF 2018-10-04

HYBRID Guidewire

Applicant Balt USA, LLC

K number K182337

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MOF 2018-08-07

Volo 14 Guidewire, 200cm, Soft Profile, Volo 14 Guidewire, 200cm, Standard Profile, Volo 14 Guidewire, 300cm, Soft Profile, Volo 14 Guidewire, 300cm, Standard Profile

Applicant Scientia Vascular, LLC

K number K181828

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MOF 2017-07-01

ASAHI Neurovasulature Guide Wire: ASAHI CHIKAI black 18 soft tip

Applicant Asahi Intecc Co., Ltd.

K number K171613

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MOF 2016-12-09

Traxcess 7 Mini XSoft Guidewire

Applicant MicroVention, Inc.

K number K163154

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MOF 2016-10-14

ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 14 soft tip

Applicant Asahi Intecc Co., Ltd.

K number K161912

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MOF 2016-09-30

Traxcess .007 Mini Guidewire

Applicant MicroVention, Inc.

K number K161803

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MOF 2016-04-07

ASAHI CHIKAI Neurovascular Guide Wire (Round Curve)

Applicant Asahi Intecc Co., Ltd.

K number K160659

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MOF 2011-12-01

ASAHI CHIKAI 10 NEUROVASCULAR GUIDE WIRE

Applicant Asahi Intecc Co., Ltd.

K number K112979

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MOF 2011-08-22

ASAHI CHIKAI NEUROVASCULAR GUIDE WIRE

Applicant Asahi Intecc Co., Ltd.

K number K110584

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