# K091385: Approach Hydro ST Wire Guide, Model HMW

- Pathway: 510(k) (Special)
- Applicant: Cook, Inc.
- Decided: Aug 7, 2009 after 89 days
- Product code: DQX (Wire, Guide, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1330
- 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.
4 later devices descend from it; 2 cite it directly.
2 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K110009: Roadrunner Uniglide Hydrophilic Wire Guide (2011), 2 descendants of its own
- K250203: SureAx-Guide™ (2025), 0 descendants of its own
- K130766: Roadrunner Uniglide Hydrophilic Wire Guide (2013), 0 descendants of its own
- K123707: Alight 16 Superselective Microwire Guide (2013), 0 descendants of its own

## Recalls of this device
- Oct 8, 2024 · Class II · Z-0347-2025: Affected device lots have labels that state the incorrect expiration dates.

## Indications for use
Indicated for use in facilitating delivery of percutaneous catheters into the peripheral vasculature.

Source page: https://510kreport.com/device/K091385
Methodology: https://510kreport.com/methodology