# K000011: Modified Hydrophilic Coated Guidewire

- Pathway: 510(k) (Special)
- Applicant: Lake Region Mfg., Inc.
- Decided: Mar 1, 2000 after 58 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.
13 later devices descend from it; 3 cite it directly.
0 of 14 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
- K092303: Merit Laureate Hydrophilic Guide Wire (2009), 9 descendants of its own
- K120644: Merit Hydrophilic Guide Wire (2012), 8 descendants of its own
- K130588: Merit Hydrophilic Guide Wire (2013), 6 descendants of its own
- K131710: Merit Hydrophilic Guide Wire (2013), 5 descendants of its own
- K123609: Merit Hydrophilic Guide Wire (2013), 5 descendants of its own

Source page: https://510kreport.com/device/K000011
Methodology: https://510kreport.com/methodology