# K003084: Concentric Hydrophilic Guidewire, Models 90011, 90012

- Pathway: 510(k) (Traditional)
- Applicant: Concentric Medical, Inc.
- Decided: May 16, 2001 after 225 days
- Product code: DQX (Wire, Guide, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1330
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 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
- K040825: Lake Region Hydrophilic Guidewire (2004), 1 descendant of its own
- K081775: The Medcomp .010 Vascular Guidewires (2009), 0 descendants of its own

Source page: https://510kreport.com/device/K003084
Methodology: https://510kreport.com/methodology