Class Class II
SmartGUIDE deflectable hydrophilic guidewire (K222690)
Description
SmartGUIDE deflectable hydrophilic guidewire by Artiria Medical SA, an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK222690
Clearance Date2023-04-24
Clearance TypeTraditional
Product CodeMOF
Regulation Number870.1330
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K222690
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. SmartGUIDE deflectable hydrophilic guidewire (K222690) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K200374 | Columbus Guidewire | Rapid-Medical , Ltd. | 2020 |
| K190843 | Synchro2 Support Guidewire | Stryker | 2019 |
| K053268 | PVS 2000 SYNCHRO2 GUIDEWIRE | Boston Scientific - Precision Vascular | 2006 |
Trace the full predicate network for K222690
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.