# K262391: APRO 35 Swift Catheter and Alembic Aspiration Tubing

- Pathway: 510(k) (Special)
- Applicant: Alembic, LLC
- Decided: Aug 12, 2026 after 29 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: 12 generations back to K003410 (2001). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K251015: APRO 45 Catheter and Alembic Aspiration Tubing, Alembic, LLC (2025) Summary page 5.

## Indications for use
The APRO® 35 Swift 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® 35 Swift Catheter to the aspiration pump.

Source page: https://510kreport.com/device/K262391
Methodology: https://510kreport.com/methodology