# K251828: CEREGLIDE 71 Catheter System; Cerenovus Aspiration Tubing Set

- Pathway: 510(k) (Special)
- Applicant: Cerenovus, Inc.
- Decided: Aug 22, 2025 after 70 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). 29 ancestors in all.
No later device cites it as a predicate yet.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221934: CEREGLIDE 71 Intermediate Catheter; Cerenovus Aspiration Tubing Set, Cerenovus, Inc. (2023) Summary page 5.
- K221930: CEREGLIDE 71 Intermediate Catheter, Cerenovus, Inc. (2023) Summary page 5.

## Indications for use
Product Code NRY: The CEREGLIDE 71 Catheter System, with the Cerenovus 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 Cerenovus Aspiration Tubing Set is intended to connect the Cerenovus Large Bore Catheter or the CEREGLIDE 71, 57, or 42 Intermediate Catheter to the canister of a compatible aspiration pump and to allow the user to control the fluid flow. Product Code QJP: The CEREGLIDE 71 Catheter System is indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the neurovascular system. The CEREGLIDE 71 Catheter System is also indicated for use as a conduit for retrieval devices.

Source page: https://510kreport.com/device/K251828
Methodology: https://510kreport.com/methodology