# K112404: Concentric Balloon Guide Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Concentric Medical, Inc.
- Decided: Mar 15, 2012 after 206 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: 3 generations back to K010954 (2001). 3 ancestors in all.
47 later devices descend from it; 4 cite it directly.
0 of 51 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102657: Concentric Balloon Guide Catheter, Concentric Medical, Inc. (2010) Summary page 1.

## Most influential descendants
- K133177: Modified HD Guide Catheter (2014), 28 descendants of its own
- K151667: AXS Catalyst Distal Access Catheter 058x115cm, AXS Catalyst Distal Access Catheter 058x132cm, AXS Catalyst Distal Access Catheter 060x132cm (2015), 26 descendants of its own
- K180715: React 68 Catheter (2018), 19 descendants of its own
- K122581: Modified Balloon Guide Catheter Model 90253, 90254 (2012), 15 descendants of its own
- 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 (2019), 14 descendants of its own

## Recalls of this device
- Nov 13, 2018 · Class II · Z-0065-2020: Labeling error; 8F Balloon Guide Catheters have been packaged within 9F Balloon Guide Catheter packaging

## Indications for use
The Concentric Balloon Guide Catheter is indicated for use in facilitating the insertion and guidance of an 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/K112404
Methodology: https://510kreport.com/methodology