Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart B — Cardiovascular Diagnostic Devices](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices) → [21 CFR 870.1330](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1330) → MOF — Guide, Wire, Catheter, Neurovasculature # MOF · Guide, Wire, Catheter, Neurovasculature _Cardiovascular · 21 CFR 870.1330 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MOF ## Overview - **Product Code:** MOF - **Device Name:** Guide, Wire, Catheter, Neurovasculature - **Regulation:** [21 CFR 870.1330](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1330) - **Device Class:** 2 - **Review Panel:** [Cardiovascular](/submissions/CV) - **3rd-party reviewable:** yes ## Identification A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel. ## Classification Rationale Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9. ## Special Controls *Classification.* Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9. ## Recent Cleared Devices (20 of 39) Showing 20 most recent of 39 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K252317](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MOF/K252317.md) | Zenith Micro Guidewire | Suzhou Zenith Vascular SciTech Limited | Apr 16, 2026 | SESE | | [K260537](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MOF/K260537.md) | Willow 24 Guidewire | Arbor Endovascular, LLC | Mar 19, 2026 | SESE | | [K252122](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MOF/K252122.md) | DCwire Micro-guidewire | Shanghai Achieva Medical Suzhou Co., Ltd. | Mar 16, 2026 | SESE | | [K260130](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MOF/K260130.md) | Willow 18 Guidewire | Arbor Endovascular, LLC | Feb 13, 2026 | SESE | | [K252011](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MOF/K252011.md) | CHIKAI Nexus petit | Asahi Intecc Co., Ltd. | Feb 2, 2026 | SESE | | [K253168](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MOF/K253168.md) | 0.014” Willow Guidewire | Arbor Endovascular, LLC | Nov 26, 2025 | SESE | | [K244061](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MOF/K244061.md) | X-Wire Guidewire | Imperative Care, Inc. | Aug 26, 2025 | SESE | | [K243756](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MOF/K243756.md) | 0.014” Willow Guidewire | Arbor Endovascular, LLC | Jul 17, 2025 | SESE | | [K243383](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MOF/K243383.md) | CHIKAI Nexus 014 | Asahi Intecc Co., Ltd. | Apr 21, 2025 | SESE | | [K243938](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MOF/K243938.md) | Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire; Aristotle Colossus Guidewire | Scientia Vascular, Inc. | Apr 1, 2025 | SESE | | [K240871](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MOF/K240871.md) | Synxess Neurovascular Guidewire | Enlight Medical Technologies (Shenzhen) Co., Ltd. | Nov 18, 2024 | SESE | | [K233791](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MOF/K233791.md) | Drivewire 24 Guidewire | Rapid-Medical , Ltd. | Jul 11, 2024 | SESE | | [K231954](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MOF/K231954.md) | Aristotle 18 Guidewire; Aristotle 24 Guidewire | Scientia Vascular, Inc. | Aug 1, 2023 | SESE | | [K222690](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MOF/K222690.md) | SmartGUIDE deflectable hydrophilic guidewire | Artiria Medical SA | Apr 24, 2023 | SESE | | [K220398](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MOF/K220398.md) | Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 Guidewire; Zoom Wire 14 Guidewire | Scientia Vascular, LLC | Mar 10, 2023 | SESE | | [K222437](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MOF/K222437.md) | Aristotle Colossus Guidewire | Scientia Vascular, Inc. | Jan 26, 2023 | SESE | | [K220934](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MOF/K220934.md) | RADIFOCUS Torque Device | Terumo Medical Products (Hangzhou) Co., Ltd. | Jun 29, 2022 | SESE | | [K200374](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MOF/K200374.md) | Columbus Guidewire | Rapid-Medical , Ltd. | Dec 14, 2020 | SESE | | [K202522](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MOF/K202522.md) | Synchro SELECT Guidewire | Stryker Neurovascular | Sep 25, 2020 | SESE | | [K201487](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MOF/K201487.md) | Traxcess 7 Mini Guidewire | MicroVention, Inc. | Jul 2, 2020 | SESE | ## Top Applicants - Asahi Intecc Co., Ltd. — 10 clearances - MicroVention, Inc. — 6 clearances - Arbor Endovascular, LLC — 4 clearances - Scientia Vascular, Inc. — 3 clearances - Scientia Vascular, LLC — 3 clearances --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MOF](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MOF) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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