Class Class II
X-Wire Guidewire (K244061)
Description
X-Wire Guidewire by Imperative Care, Inc., an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK244061
Clearance Date2025-08-26
Clearance TypeTraditional
Product CodeMOF
Regulation Number870.1330
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K244061
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. X-Wire Guidewire (K244061) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K231954 | Aristotle 18 Guidewire; Aristotle 24 Guidewire | Scientia Vascular, Inc. | 2023 |
| K220398 | Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 2... | Scientia Vascular, LLC | 2023 |
Trace the full predicate network for K244061
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.