# K102657: Concentric Balloon Guide Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Concentric Medical, Inc.
- Decided: Nov 17, 2010 after 63 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: 2 generations back to K010954 (2001). 2 ancestors in all.
48 later devices descend from it; 1 cites 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)
- K010954: Concentric Balloon Guide Catheter, Model 90031, Concentric Medical, Inc. (2001) Summary page 1.
- K021899: Concentric Balloon Guide Catheter, Model 90072, Concentric Medical, Inc. (2002) Summary page 1.

## Most influential descendants
- K112404: Concentric Balloon Guide Catheter (2012), 47 descendants of its own
- 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

## 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 the Merci Retriever.

Source page: https://510kreport.com/device/K102657
Methodology: https://510kreport.com/methodology