# K191237: CERENOVUS Large Bore Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Codman & Shurtleff, Inc.
- Decided: Nov 8, 2019 after 184 days
- Product code: DQY (Catheter, Percutaneous)
- 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: 8 generations back to K003880 (2001). 13 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183463: AXS Catalyst Distal Access Catheter 068 x 115cm, AXS Catalyst Distal Access Catheter 068 x 125cm, AXS Catalyst Distal Access Catheter 068 x 132cm, Stryker (2019) Summary page 5.

## Most influential descendants
- K193380: CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set (2020), 3 descendants of its own
- K221930: CEREGLIDE 71 Intermediate Catheter (2023), 1 descendant of its own
- 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 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 CERENOVUS Large Bore Catheter is also indicated for use as a conduit for retrieval devices.

Source page: https://510kreport.com/device/K191237
Methodology: https://510kreport.com/methodology