# K220331: 091 Balloon Guide Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Inneuroco, Inc.
- Decided: Jul 29, 2022 after 175 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: 4 generations back to K010954 (2001). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112404: Concentric Balloon Guide Catheter, Concentric Medical, Inc. (2012) Summary page 4.

## Most influential descendants
- K231629: 091 Balloon Guide Catheter (2023), 0 descendants of its own

## Indications for use
The 091 Balloon Guide Catheter is indicated for use in facilitating the insertion and guidance of intravascular catheters into a selected blood vessel in the peripheral and neuro vascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. The Balloon Guide Catheter is also indicated for use as a conduit for Retrieval devices.

Source page: https://510kreport.com/device/K220331
Methodology: https://510kreport.com/methodology