CHIKAI Nexus petit— 510(k) K252011
Substantially EquivalentAsahi Intecc Co., Ltd.
FDA 510(k) clearance K252011 for CHIKAI Nexus petit, Substantially Equivalent on 2026-02-02. Applicant: Asahi Intecc Co., Ltd.. Device class: 2.
Summary
Asahi Intecc's CHIKAI Nexus petit is filed under product code MOF (Guide, Wire, Catheter, Neurovasculature). The record doesn't describe it beyond the name and that code name.
Class II, 21 CFR 870.1330. The Neurology review panel handled it as a Traditional 510(k), though the record lists Cardiovascular as the classification panel.
Asahi Intecc filed from Seto, Japan. The substantially equivalent decision came 220 calendar days after receipt (June 27, 2025 to February 2, 2026).
Clearance details
- Applicant
- Asahi Intecc Co., Ltd.
- Product code
- Product code MOF
- Device class
- Class 2
- Regulation
- 21 CFR 870.1330
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Seto, JP
Recent devices under product code MOF
view allMore clearances from Asahi Intecc Co., Ltd.
view allAdverse events under product code MOF
product code MOF- Death
- 6
- Injury
- 137
- Total
- 143
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.