Indigo® Aspiration System – Lightning Bolt Aspiration Tubing (K223186)
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 K223186
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 (K223186) cites 3 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K223168 | Tubing and Accessories Sets for Extracorporeal Membrane Oxy... | Medtronic, Inc. | 2023 |
| K210323 | Indigo Aspiration System - Lightning Aspiration Tubing | Penumbra, Inc. | 2021 |
| K210083 | Indigo System Aspiration Catheter 7, Indigo Aspiration Syst... | Penumbra, Inc. | 2021 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K242075 | Indigo® Aspiration System - Lightning Bolt Aspiration Tubing | Penumbra, Inc. | 2024 |
Trace the full predicate network for K223186
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.