# K251015: APRO 45 Catheter and Alembic Aspiration Tubing

- Pathway: 510(k) (Special)
- Applicant: Alembic, LLC
- Decided: Apr 30, 2025 after 28 days
- Product code: NRY (Catheter, Thrombus Retriever)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K003410 (2001). 15 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232971: APRO 55 Catheter and Alembic Aspiration Tubing, Alembic, LLC (2024) Summary page 5.

## Most influential descendants
- K262391: APRO 35 Swift Catheter and Alembic Aspiration Tubing (2026), 0 descendants of its own

## Indications for use
The APRO 45 Catheter with an aspiration pump and the Alembic Aspiration Tubing is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral – M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for thrombolytic drug therapy or who failed thrombolytic drug therapy are candidates for treatment. The Alembic Aspiration Tubing is intended to connect the APRO 45 Catheter to the aspiration pump.

Source page: https://510kreport.com/device/K251015
Methodology: https://510kreport.com/methodology