# K021899: Concentric Balloon Guide Catheter, Model 90072

- Pathway: 510(k) (Special)
- Applicant: Concentric Medical, Inc.
- Decided: Jul 10, 2002 after 30 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: 1 generation back to K010954 (2001). 1 ancestor in all.
186 later devices descend from it; 5 cite it directly.
4 of 188 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.

## Most influential descendants
- K053491: Penumbra Balloon Guide Catheter, Model 7.5F (2006), 106 descendants of its own
- K070970: Neuron Support Catheter System, Model 5F/6F (2007), 105 descendants of its own
- K082290: Neuron Delivery Catheter 070 (2008), 88 descendants of its own
- K083125: Neuron Select Catheter Size 070 (2008), 86 descendants of its own
- K111380: Neuron Max System (2011), 61 descendants of its own

## Recalls of this device
- Feb 27, 2009 · Not classified · Z-0899-2011: Product malfunction-- hub may leak at connection to the shaft due to insufficient adhesive curing.

## Indications for use
The Concentric Balloon Guide Catheter is indicated for use in facilitating 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.

Source page: https://510kreport.com/device/K021899
Methodology: https://510kreport.com/methodology