Class Class II
APRO 55 Intermediate Catheter (K250962)
Description
APRO 55 Intermediate Catheter by Alembic, LLC, an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250962
Clearance Date2025-04-29
Clearance TypeSpecial
Product CodeDQY
Regulation Number870.1250
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250962
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 55 Intermediate Catheter (K250962) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K243297 | APRO 70 Swift Catheter | Alembic, LLC | 2025 |
| K234115 | APRO 55 Catheter | Alembic, LLC | 2024 |
Trace the full predicate network for K250962
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.