Class Class II
Indigo® Aspiration System – Aspiration Catheter 6X (K242319)
Description
Indigo® Aspiration System – Aspiration Catheter 6X by Penumbra, Inc., an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242319
Clearance Date2024-09-03
Clearance TypeSpecial
Product CodeQEW
Regulation Number870.5150
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242319
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. Indigo® Aspiration System – Aspiration Catheter 6X (K242319) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K211654 | Penumbra System (Reperfusion Catheter RED 72) | Penumbra, Inc. | 2021 |
| K191946 | Penumbra System Penumbra JET 7X | Penumbra, Inc. | 2020 |
| K192833 | Indigo Aspiration System | Penumbra, Inc. | 2019 |
Trace the full predicate network for K242319
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.