Class Class II
CROSSLEAD Tracker (K241510)
Description
CROSSLEAD Tracker by Asahi Intecc Co., Ltd., an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK241510
Clearance Date2024-08-14
Clearance TypeSpecial
Product CodeDQX
Regulation Number870.1330
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241510
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 Tracker (K241510) cites 5 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K192599 | ASAHI PTCA Guide Wire ASAHI Gaia Next | Asahi Intecc Co., Ltd. | 2020 |
| K190176 | MINAMO | Asahi Intecc Co., Ltd. | 2019 |
| K163426 | ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAH... | Asahi Intecc Co., Ltd. | 2017 |
| K150445 | ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Ha... | Asahi Intecc Co., Ltd. | 2015 |
| K083146 | ASAHI REGALIA XS 1.0 PERIPHERAL GUIDE WIRE, MODELS PAGP 140... | Asahi Intecc Co., Ltd. | 2008 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K242597 | CROSSLEAD 0.018inch | Asahi Intecc Co., Ltd. | 2025 |
Trace the full predicate network for K241510
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.