Class Class II
SENDERO MAX Delivery Catheter (K242644)
Description
SENDERO MAX Delivery Catheter by Okami Medical, Inc., an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242644
Clearance Date2024-12-20
Clearance TypeTraditional
Product CodeDQY
Regulation Number870.1250
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242644
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. SENDERO MAX Delivery Catheter (K242644) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K240384 | SENDERO Microcatheter | Okami Medical, Inc. | 2024 |
| K140080 | ENVOY DISTAL ACCESS (DA) GUIDING CATHETER, 6F, 95CM & 105CM... | Codman & Shurtleff, Inc. | 2014 |
Trace the full predicate network for K242644
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.