Class Class II
Glidewire GT-R (K240859)
Description
Glidewire GT-R by Terumo Corporation, an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK240859
Clearance Date2024-08-21
Clearance TypeTraditional
Product CodeDQX
Regulation Number870.1330
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K240859
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. Glidewire GT-R (K240859) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K170417 | Glidewire GT | Terumo Corporation | 2017 |
| K111485 | FATHOM 16 STEERABLE GUIDEWIRE MODEL M001509XXX | Boston Scientific Corporation | 2011 |
| K111498 | FATHOM (TM) 14 STEERABLE GUIDEWIRE | Boston Scientific Corp | 2011 |
Trace the full predicate network for K240859
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.