# K122581: Modified Balloon Guide Catheter Model 90253, 90254

- Pathway: 510(k) (Traditional)
- Applicant: Concentric Medical, Inc.
- Decided: Nov 21, 2012 after 90 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 1 (0 Class I)
- 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.
15 later devices descend from it; 2 cite it directly.
0 of 20 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 1.

## Most influential descendants
- K131492: Modified Flowgate Balloon Guide Catheter (2013), 13 descendants of its own
- K153729: 8F FlowGate2 Balloon Guide Catheter (2016), 10 descendants of its own
- K242392: Path BGC (2025), 1 descendant of its own
- K212340: EMBOGUARD Balloon Guide Catheter (2021), 1 descendant of its own
- K193607: BOBBY Balloon Guide Catheter (2020), 1 descendant of its own

## Recalls of this device
- Dec 20, 2012 · Class II · Z-0655-2013: Firm received complaints of resistance and possible collapse of the distal tip of the FlowGate Balloon Guide Catheters during use for aspiration.

## Indications for use
The Concentric Balloon Guide Catheter is indicated for use in facilitating the insertion and guidance of intravascular catheter 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/K122581
Methodology: https://510kreport.com/methodology