# K081775: The Medcomp .010 Vascular Guidewires

- Pathway: 510(k) (Traditional)
- Applicant: Medcomp
- Decided: Mar 25, 2009 after 275 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: 2 generations back to K770977 (1977). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040825: Lake Region Hydrophilic Guidewire, Lake Region Mfg., Inc. (2004) Summary page 1.
- K033758: Hydrophilic Guidewire, Lake Region Mfg., Inc. (2003) Summary page 1.
- K011084: Mandrel Guidewire Assembly, Lake Region Mfg., Inc. (2001)

## Indications for use
The Medcomp .010" Vascular Guidewires are indicated for general intravascular use, including the peripheral vasculature, to facilitate the selective placement of medical devices in the vessel anatomy. This device is not intended for coronary or cerebrovascular use.

Source page: https://510kreport.com/device/K081775
Methodology: https://510kreport.com/methodology