# K212340: EMBOGUARD Balloon Guide Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Neuravi Limited
- Decided: Dec 17, 2021 after 142 days
- Product code: QJP (Catheter, Percutaneous, Neurovasculature)
- 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 K010954 (2001). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153729: 8F FlowGate2 Balloon Guide Catheter, Concentric Medical (2016) Summary page 4.

## Most influential descendants
- K233924: EMBOGUARD Balloon Guide Catheter (2024), 0 descendants of its own

## Indications for use
EMBOGUARD Balloon Guide Catheters are indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the neurovascular system. The balloon provides temporary vascular occlusion during angiographic procedures. The Balloon Guide Catheter is also indicated for use as a conduit for Retrieval Devices.

Source page: https://510kreport.com/device/K212340
Methodology: https://510kreport.com/methodology