Class Class II
CHIKAI Nexus 014 (K243383)
Description
CHIKAI Nexus 014 by Asahi Intecc Co., Ltd., an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243383
Clearance Date2025-04-21
Clearance TypeTraditional
Product CodeMOF
Regulation Number870.1330
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243383
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. CHIKAI Nexus 014 (K243383) cites 5 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K191714 | ASAHI Neurovascular Guide Wire CHIKAI X 014 soft | Asahi Intecc Co., Ltd. | 2019 |
| K163426 | ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAH... | Asahi Intecc Co., Ltd. | 2017 |
| K160659 | ASAHI CHIKAI Neurovascular Guide Wire (Round Curve) | Asahi Intecc Co., Ltd. | 2016 |
| K141751 | ASAHI NEUROVASCULAR GUIDE WIRE ASAHI CHIKAI 008, ASAHI NEUR... | Asahi Intecc Co., Ltd. | 2015 |
| K022762 | JOWIRE NEO'S PTCA CATHETER GUIDEWIRES, MODELS AG141000, AG1... | Jomed, Inc. | 2002 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K243382 | RZ Resectoscope System | Rz Medizintechnik GmbH | 2025 |
Trace the full predicate network for K243383
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.