# K221934: CEREGLIDE 71 Intermediate Catheter; Cerenovus Aspiration Tubing Set

- Pathway: 510(k) (Traditional)
- Applicant: Cerenovus, Inc.
- Decided: Mar 9, 2023 after 251 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). 27 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193380: CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set, Codman & Shurtleff, Inc. (2020) Summary page 4.

## Most influential descendants
- K251828: CEREGLIDE 71 Catheter System; Cerenovus Aspiration Tubing Set (2025), 0 descendants of its own

## Indications for use
CEREGLIDE™ 71 Intermediate Catheter The CEREGLIDE™ 71 Intermediate Catheter, 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 intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment. Cerenovus Aspiration Tubing Set The Cerenovus Aspiration Tubing Set is intended to connect the Cerenovus Large Bore Catheter to the canister of the Nouvag Vacuson 60 Aspiration Pump (or equivalent vacuum pump) and to allow the user to control the fluid flow. The Cerenovus Aspiration Tubing Set is also intended to connect the CEREGLIDE™ 71 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/K221934
Methodology: https://510kreport.com/methodology