# K010954: Concentric Balloon Guide Catheter, Model 90031

- Pathway: 510(k) (Traditional)
- Applicant: Concentric Medical, Inc.
- Decided: Oct 9, 2001 after 193 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
No predicates in its family tree.
187 later devices descend from it; 3 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K021899: Concentric Balloon Guide Catheter, Model 90072 (2002), 186 descendants of its own
- 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

## 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

Source page: https://510kreport.com/device/K010954
Methodology: https://510kreport.com/methodology