# K083713: .035 Loc Guide Wire Extension

- Pathway: 510(k) (Special)
- Applicant: Abbott Vascular
- Decided: Feb 23, 2009 after 70 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Mallinckrodt branded LOC Guide Wire Extension 115cm: named in the summary without a submission number

## Indications for use
The .035 LOC Guide Wire Extension is intended to provide the necessary length to allow the exchange of one catheter for another while maintaining the position of the guide wire in the artery. After the catheter exchange has been completed, the extension can be detached and the initial wire can be used as a conventional guide wire.

Source page: https://510kreport.com/device/K083713
Methodology: https://510kreport.com/methodology