# K193380: CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set

- Pathway: 510(k) (Traditional)
- Applicant: Codman & Shurtleff, Inc.
- Decided: Jul 20, 2020 after 228 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). 26 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161064: Penumbra System ACE 68 Reperfusion Catheter, Penumbra, Inc. (2016) Summary page 4.
- K191237: CERENOVUS Large Bore Catheter, Codman & Shurtleff, Inc. (2019) Summary page 4.

## Most influential descendants
- K221934: CEREGLIDE 71 Intermediate Catheter; Cerenovus Aspiration Tubing Set (2023), 1 descendant of its own
- K251828: CEREGLIDE 71 Catheter System; Cerenovus Aspiration Tubing Set (2025), 0 descendants of its own
- K233988: Cerenovus Large Bore Catheter; Cerenovus Aspiration Tubing Set (2024), 0 descendants of its own

## Indications for use
The CERENOVUS Large Bore Catheter, with the CERENOVUS® Aspiration Tubing Set and NOUVAG Vacuson 60 aspiration pump (or equivalent 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 failed IV t-PA are candidates for treatment. 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.

Source page: https://510kreport.com/device/K193380
Methodology: https://510kreport.com/methodology