MOF · Guide, Wire, Catheter, Neurovasculature
Cardiovascular · 21 CFR 870.1330 · Class 2
Overview
| Product Code | MOF |
|---|---|
| Device Name | Guide, Wire, Catheter, Neurovasculature |
| Regulation | 21 CFR 870.1330 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 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 | Zenith Micro Guidewire | Suzhou Zenith Vascular SciTech Limited | Apr 16, 2026 | SESE |
| K260537 | Willow 24 Guidewire | Arbor Endovascular, LLC | Mar 19, 2026 | SESE |
| K252122 | DCwire Micro-guidewire | Shanghai Achieva Medical Suzhou Co., Ltd. | Mar 16, 2026 | SESE |
| K260130 | Willow 18 Guidewire | Arbor Endovascular, LLC | Feb 13, 2026 | SESE |
| K252011 | CHIKAI Nexus petit | Asahi Intecc Co., Ltd. | Feb 2, 2026 | SESE |
| K253168 | 0.014 Willow Guidewire | Arbor Endovascular, LLC | Nov 26, 2025 | SESE |
| K244061 | X-Wire Guidewire | Imperative Care, Inc. | Aug 26, 2025 | SESE |
| K243756 | 0.014 Willow Guidewire | Arbor Endovascular, LLC | Jul 17, 2025 | SESE |
| K243383 | CHIKAI Nexus 014 | Asahi Intecc Co., Ltd. | Apr 21, 2025 | SESE |
| K243938 | Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire; Aristotle Colossus Guidewire | Scientia Vascular, Inc. | Apr 1, 2025 | SESE |
| K240871 | Synxess Neurovascular Guidewire | Enlight Medical Technologies (Shenzhen) Co., Ltd. | Nov 18, 2024 | SESE |
| K233791 | Drivewire 24 Guidewire | Rapid-Medical , Ltd. | Jul 11, 2024 | SESE |
| K231954 | Aristotle 18 Guidewire; Aristotle 24 Guidewire | Scientia Vascular, Inc. | Aug 1, 2023 | SESE |
| K222690 | SmartGUIDE deflectable hydrophilic guidewire | Artiria Medical SA | Apr 24, 2023 | SESE |
| K220398 | Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 Guidewire; Zoom Wire 14 Guidewire | Scientia Vascular, LLC | Mar 10, 2023 | SESE |
| K222437 | Aristotle Colossus Guidewire | Scientia Vascular, Inc. | Jan 26, 2023 | SESE |
| K220934 | RADIFOCUS Torque Device | Terumo Medical Products (Hangzhou) Co., Ltd. | Jun 29, 2022 | SESE |
| K200374 | Columbus Guidewire | Rapid-Medical , Ltd. | Dec 14, 2020 | SESE |
| K202522 | Synchro SELECT Guidewire | Stryker Neurovascular | Sep 25, 2020 | SESE |
| K201487 | 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
