Indigo® Aspiration System – Lightning Bolt Aspiration Tubing (K242075)
Description
Indigo® Aspiration System – Lightning Bolt Aspiration Tubing by Penumbra, Inc., an FDA 510(k) cleared cardiovascular device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242075
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 – Lightning Bolt Aspiration Tubing (K242075) cites 4 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K223186 | Indigo® Aspiration System Lightning Bolt Aspiration Tubing | Penumbra, Inc. | 2023 |
| K210083 | Indigo System Aspiration Catheter 7, Indigo Aspiration Syst... | Penumbra, Inc. | 2021 |
| K202821 | Indigo Aspiration System - Aspiration Catheter 12 and Separ... | Penumbra, Inc. | 2020 |
| K192833 | Indigo Aspiration System | Penumbra, Inc. | 2019 |
Trace the full predicate network for K242075
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.