# 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

- Pathway: 510(k) (Traditional)
- Applicant: Stryker
- Decided: Mar 18, 2018 after 90 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: 9 generations back to K003410 (2001). 13 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090752: Penumbra System (Pennumbra Reperfusion Catheter 054), Model PSC054; (Penumbra Separator 054), Model PSS054, Penumbra, Inc. (2009) Summary page 5.
- K160449: Penumbra System, Penumbra Pump MAX, Penumbra, Inc. (2016) Summary page 5.

## Most influential descendants
- K232971: APRO 55 Catheter and Alembic Aspiration Tubing (2024), 4 descendants of its own
- 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 AXS Catalyst Distal Access Catheter as part of the AXS Universal Aspiration System is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (in 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 failed IV t-PA are candidates for treatment.

Source page: https://510kreport.com/device/K173841
Methodology: https://510kreport.com/methodology