Class Class II
APRO 70 Catheter and Alembic Aspiration Tubing (K223545)
Description
APRO 70 Catheter and Alembic Aspiration Tubing by Alembic, LLC, an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223545
Clearance Date2023-02-17
Clearance TypeTraditional
Product CodeNRY
Regulation Number870.1250
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223545
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. APRO 70 Catheter and Alembic Aspiration Tubing (K223545) cites 2 predicate devices and is itself cited by 5 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K173200 | SOFIA Plus Aspiration Catheter | MicroVention, Inc. | 2018 |
| K142458 | Penumbra System ACE | Penumbra, Inc. | 2015 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K243287 | APRO 70 Swift Catheter and Alembic Aspiration Tubing | Alembic, LLC | 2025 |
| K243297 | APRO 70 Swift Catheter | Alembic, LLC | 2025 |
| K234115 | APRO 55 Catheter | Alembic, LLC | 2024 |
| K232971 | APRO 55 Catheter and Alembic Aspiration Tubing | Alembic, LLC | 2024 |
| K230695 | APRO 70 Catheter and Alembic Aspiration Tubing | Alembic, LLC | 2023 |
Trace the full predicate network for K223545
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.