# K241221: CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing Set

- Pathway: 510(k) (Traditional)
- Applicant: Cerenovus, Inc.
- Decided: Oct 16, 2024 after 168 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: 7 generations back to K003410 (2001). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190338: 046 Zenith Flex, Inneuroco, Inc. (2019) Summary page 5.

## Most influential descendants
- K262398: CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing set (2026), 0 descendants of its own

## Indications for use
The CEREGLIDE 42 Intermediate Catheter and the CEREGLIDE 57 Intermediate Catheter, with the Cerenovus Aspiration Tubing Set and a compatible aspiration pump, are 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 - Ml 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.

Source page: https://510kreport.com/device/K241221
Methodology: https://510kreport.com/methodology