Class Class II
CROSSLEAD 0.014inch (K241702)
Description
CROSSLEAD 0.014inch by Asahi Intecc Co., Ltd., an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK241702
Clearance Date2025-02-06
Clearance TypeSpecial
Product CodeDQX
Regulation Number870.1330
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241702
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. CROSSLEAD 0.014inch (K241702) cites 5 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K230377 | CROSSLEAD Penetration Peripheral Guide Wire | Asahi Intecc Co., Ltd. | 2023 |
| K190176 | MINAMO | Asahi Intecc Co., Ltd. | 2019 |
| K163426 | ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAH... | Asahi Intecc Co., Ltd. | 2017 |
| K153443 | ASAHI Astato XS 40 | Asahi Intecc Co., Ltd. | 2016 |
| K150445 | ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Ha... | Asahi Intecc Co., Ltd. | 2015 |
Trace the full predicate network for K241702
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.