Class Class II
Kodiak™ Dual Port Coaxial Introducer Kit (K230631)
Description
Kodiak™ Dual Port Coaxial Introducer Kit by Argon Medical Devices, an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK230631
Clearance Date2023-05-22
Clearance TypeTraditional
Product CodeDYB
Regulation Number870.1340
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K230631
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. Kodiak™ Dual Port Coaxial Introducer Kit (K230631) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K171999 | Performer Introducer | Cook Incorporated | 2017 |
Trace the full predicate network for K230631
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.