Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 Guidewire; Zoom Wire 14 Guidewire (K220398)
Description
Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 Guidewire; Zoom Wire 14 Guidewire by Scientia Vascular, LLC, an FDA 510(k) cleared cardiovascular device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K220398
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 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 Guidewire; Zoom Wire 14 Guidewire (K220398) cites 5 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K201760 | Zoom 14 Guidewire | Scientia Vascular, LLC | 2020 |
| K192783 | Aristotle 24 Guidewire, 200cm, Soft Profile ; Aristotle 24 ... | Scientia Vascular, LLC | 2019 |
| K183608 | Aristotle 18 Guidewire, 200cm, Soft Profile ; Aristotle 18 ... | Scientia Vascular, LLC | 2019 |
| K181828 | Volo 14 Guidewire, 200cm, Soft Profile, Volo 14 Guidewire, ... | Scientia Vascular, LLC | 2018 |
| K173235 | Aristotle 14 Guidewire, 200cm, Soft Profile, Aristotle 14 G... | Scientia Vascular, LLC | 2018 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K244061 | X-Wire Guidewire | Imperative Care, Inc. | 2025 |
Trace the full predicate network for K220398
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.