Class Class II
Aristotle Colossus Guidewire (K222437)
Description
Aristotle Colossus Guidewire by Scientia Vascular, Inc., an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK222437
Clearance Date2023-01-26
Clearance TypeTraditional
Product CodeMOF
Regulation Number870.1330
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K222437
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. Aristotle Colossus Guidewire (K222437) cites 2 predicate devices and is itself cited by 2 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K192783 | Aristotle 24 Guidewire, 200cm, Soft Profile ; Aristotle 24 ... | Scientia Vascular, LLC | 2019 |
| K141751 | ASAHI NEUROVASCULAR GUIDE WIRE ASAHI CHIKAI 008, ASAHI NEUR... | Asahi Intecc Co., Ltd. | 2015 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K243938 | Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 2... | Scientia Vascular, Inc. | 2025 |
| K231954 | Aristotle 18 Guidewire; Aristotle 24 Guidewire | Scientia Vascular, Inc. | 2023 |
Trace the full predicate network for K222437
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.