# K033758: Hydrophilic Guidewire

- Pathway: 510(k) (Special)
- Applicant: Lake Region Mfg., Inc.
- Decided: Dec 19, 2003 after 17 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
Longest line of descent: 1 generation back to K770977 (1977). 2 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K770977: Cardiovascular Spring Guides, Lake Region Mfg., Inc. (1977) Summary page 2.
- K011084: Mandrel Guidewire Assembly, Lake Region Mfg., Inc. (2001) Summary page 2.

## Most influential descendants
- K140485: Mandrel Guidewire (2014), 2 descendants of its own
- K142393: Predicate Iii Guidewire (2014), 1 descendant of its own
- K241784: Arrow® Nitinol Wire (2024), 0 descendants of its own
- K081775: The Medcomp .010 Vascular Guidewires (2009), 0 descendants of its own

## Indications for use
To facilitate the placement of devices for diagnostic and interventional procedures.

Source page: https://510kreport.com/device/K033758
Methodology: https://510kreport.com/methodology