CHIKAI Nexus petit
FDA 510(k) K252011 · Asahi Intecc Co., Ltd.
510(k) numberK252011
Submission
- Device name
- CHIKAI Nexus petit
- Applicant
- Asahi Intecc Co., Ltd.
Seto, JP - Received
- June 27, 2025
- Decision date
- February 2, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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
Other 510(k)s with product code MOF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260751 | 35 Helix GuidewireMOF · Traditional | Piraeus Medical, Inc. | 08/27/2026SE |
| K262424 | Willow 12 GuidewireMOF · Special | Arbor Endovascular, LLC | 08/14/2026SE |
| K260223 | Aristotle Mini GuidewireMOF · Traditional | Scientia Vascular, Inc. | 08/06/2026SE |
| K254006 | Drivewire 35 GuidewireMOF · Traditional | Rapid Medical Ltd. | 07/17/2026SE |
| K253579 | Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14…MOF · Traditional | Scientia Vascular, Inc. | 04/29/2026SE |
| K252317 | Zenith Micro GuidewireMOF · Traditional | Suzhou Zenith Vascular SciTech Limited | 04/16/2026SE |
| K260537 | Willow 24 GuidewireMOF · Special | Arbor Endovascular, LLC | 03/19/2026SE |
| K252122 | DCwire Micro-guidewireMOF · Traditional | Shanghai Achieva Medical Suzhou Co., Ltd. | 03/16/2026SE |
| K260130 | Willow 18 GuidewireMOF · Special | Arbor Endovascular, LLC | 02/13/2026SE |
| K253168 | 0.014 Willow GuidewireMOF · Special | Arbor Endovascular, LLC | 11/26/2025SE |
More from Arbor Endovascular, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K254178 | SAYA 86 Radial Access Guide CatheterQJP · Traditional | 05/11/2026SE |
| K251560 | FUBUKI XF-R Neurovascular Long SheathQJP · Special | 06/20/2025SE |
| K251240 | Branchor X Balloon Guide CatheterQJP · Traditional | 06/20/2025SE |
| K243383 | CHIKAI Nexus 014MOF · Traditional | 04/21/2025SE |
| K243733 | SION blue PLUSDQX · Special | 04/02/2025SE |
| K241962 | CrossloopDQX · Traditional | 03/27/2025SE |
| K242597 | CROSSLEAD 0.018inchDQX · Special | 03/05/2025SE |
| K241702 | CROSSLEAD 0.014inchDQX · Special | 02/06/2025SE |
| K241801 | Tornus ESFGE · Traditional | 12/17/2024SE |
| K241510 | CROSSLEAD TrackerDQX · Special | 08/14/2024SE |
Questions and answers
When was CHIKAI Nexus petit cleared by the FDA?
CHIKAI Nexus petit (K252011) received a 510(k) decision of Substantially Equivalent on February 2, 2026, 220 days after the submission was received.
What is the product code of K252011?
The FDA product code is MOF – Guide, Wire, Catheter, Neurovasculature, a Class II (moderate risk) device regulated under 21 CFR 870.1330.