# K232971: APRO 55 Catheter and Alembic Aspiration Tubing

- Pathway: 510(k) (Traditional)
- Applicant: Alembic, LLC
- Decided: Feb 29, 2024 after 161 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: 10 generations back to K003410 (2001). 14 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173841: AXS Catalyst Distal Access Catheter 058 x 115cm; AXS Catalyst Distal Access Catheter 058 x 132cm; AXS Catalyst Distal Access Catheter 060 x 132cm, Stryker (2018) Summary page 5.

## Most influential descendants
- K251015: APRO 45 Catheter and Alembic Aspiration Tubing (2025), 1 descendant of its own
- K262391: APRO 35 Swift Catheter and Alembic Aspiration Tubing (2026), 0 descendants of its own
- K250958: APRO 55 Swift Catheter and Alembic Aspiration Tubing (2025), 0 descendants of its own
- K243287: APRO 70 Swift Catheter and Alembic Aspiration Tubing (2025), 0 descendants of its own

## Indications for use
The APRO 55 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 intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment. The Alembic Aspiration Tubing is intended to connect the APRO 55 Catheter to the aspiration pump.

Source page: https://510kreport.com/device/K232971
Methodology: https://510kreport.com/methodology