Traxcess 7 Mini Guidewire
FDA 510(k) K201487 · MicroVention, Inc.
510(k) numberK201487
Submission
- Device name
- Traxcess 7 Mini Guidewire
- Applicant
- MicroVention, Inc.
Aliso Viejo, CA, US - Received
- June 4, 2020
- Decision date
- July 2, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MOF – Guide, Wire, Catheter, Neurovasculature
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1330
- Specialty
- Cardiovascular
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| K262424 | Willow 12 GuidewireMOF · Special | Arbor Endovascular, LLC | 08/14/2026SE |
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| K252317 | Zenith Micro GuidewireMOF · Traditional | Suzhou Zenith Vascular SciTech Limited | 04/16/2026SE |
| K260537 | Willow 24 GuidewireMOF · Special | Arbor Endovascular, LLC | 03/19/2026SE |
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| K260130 | Willow 18 GuidewireMOF · Special | Arbor Endovascular, LLC | 02/13/2026SE |
| K252011 | CHIKAI Nexus petitMOF · Traditional | Asahi Intecc Co., Ltd. | 02/02/2026SE |
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| K222115 | ISAAC Neurovascular Navigation CatheterDQY · Traditional | 01/10/2023SE |
| K223050 | AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880060)KRD · Traditional | 12/21/2022SE |
| K214024 | SOFIA 88 CatheterDQY · Traditional | 09/12/2022SE |
| K211120 | ERIC Retrieval DeviceNRY · Traditional | 03/31/2022SE |
| K193607 | BOBBY Balloon Guide CatheterDQY · Traditional | 07/21/2020SE |
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Questions and answers
When was Traxcess 7 Mini Guidewire cleared by the FDA?
Traxcess 7 Mini Guidewire (K201487) received a 510(k) decision of Substantially Equivalent on July 2, 2020, 28 days after the submission was received.
What is the product code of K201487?
The FDA product code is MOF – Guide, Wire, Catheter, Neurovasculature, a Class II (moderate risk) device regulated under 21 CFR 870.1330.