# K252707: Zenith Aspiration Catheter; Disposable Aspiration Tubing Set

- Pathway: 510(k) (Traditional)
- Applicant: Suzhou Zenith Vascular SciTech Limited
- Decided: May 20, 2026 after 266 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.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113163: Penumbra System Max, Penumbra, Inc. (2011) Summary page 5.
- K090752: Penumbra System (Pennumbra Reperfusion Catheter 054), Model PSC054; (Penumbra Separator 054), Model PSS054, Penumbra, Inc. (2009) Summary page 5.
- K161640: Penumbra System ACE 68 Reperfusion Catheter, Penumbra, Inc. (2016) Summary page 5.

## Indications for use
The Zenith Aspiration Catheter, with the Disposable Aspiration Tubing Set and a compatible aspiration pump, is indicated 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 Disposable Aspiration Tubing Set is indicated to connect the Zenith Aspiration Catheter to a compatible aspiration pump.

Source page: https://510kreport.com/device/K252707
Methodology: https://510kreport.com/methodology