# K192804: CEREBASE DA Guide Sheath, 95cm, CEREBASE DA Guide Sheath, 90cm, CEREBASE DA Guide Sheath, 80cm, CEREBASE DA Guide Sheath, 70cm

- Pathway: 510(k) (Traditional)
- Applicant: Medos International SARL
- Decided: Feb 27, 2020 after 149 days
- Product code: QJP (Catheter, Percutaneous, Neurovasculature)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K010954 (2001). 12 ancestors in all.
No later device cites it as a predicate yet.
1 of 13 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111380: Neuron Max System, Penumbra, Inc. (2011) Summary page 4.
- K140080: Envoy Distal Access (DA) Guiding Catheter, 6F, 95CM & 105CM, Straight & XB, MPD & XB, MPC & XB, Codman & Shurtleff, Inc. (2014) Summary page 4.
- K140307: Envoy Guiding Catheter, Codman & Shurtleff, Inc. (2014) Summary page 4.

## Recalls of this device
- Feb 2, 2024 · Class I · Z-1284-2024: Medos has received an increase in complaints for CEREBASE DA Guide Sheath with reports of fractures at the distal end, which may result in surgical procedural delay, vascular injury and in extreme rar

## Indications for use
The CEREBASE DA Guide Sheath is indicated for the introduction of interventional devices into the neuro vasculature.

Source page: https://510kreport.com/device/K192804
Methodology: https://510kreport.com/methodology