Class Class II
RAIN Sheath™ Tibial Pedal Introducer (K230704)
Description
RAIN Sheath™ Tibial Pedal Introducer by Cordis US Corp, an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK230704
Clearance Date2023-04-24
Clearance TypeTraditional
Product CodeDYB
Regulation Number870.1340
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K230704
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. RAIN Sheath™ Tibial Pedal Introducer (K230704) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K181592 | RAIN Sheath Transradial | Cordis Corporation | 2018 |
| K181237 | Glidesheath Slender Tibial Pedal Kit | Terumo Medical Corporation | 2018 |
Trace the full predicate network for K230704
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.