Class Class II
Prelude Wave Hydrophilic Sheath Introducer (K250909)
Description
Prelude Wave Hydrophilic Sheath Introducer by Merit Medical Systems, Inc., an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250909
Clearance Date2025-04-25
Clearance TypeSpecial
Product CodeDYB
Regulation Number870.1340
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250909
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. Prelude Wave Hydrophilic Sheath Introducer (K250909) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K173750 | Prelude IDeal Hydrophilic Sheath Introducer | Merit Medical Systems, Inc. | 2018 |
Trace the full predicate network for K250909
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.