# K171897: Approach CTO Microwire Guide

- Pathway: 510(k) (Traditional)
- Applicant: Cook Incorporated
- Decided: Aug 21, 2017 after 56 days
- Product code: DQX (Wire, Guide, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1330
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K890505 (1989). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070212: CITOP10 Guidewire, 0.014(1.4MM Tip), CITOP6 Guidewire, 0.014(1.0MM Tip), Citop Support Accessory, 0.023(126CM), Ovalum, Ltd. (2007) Summary page 4.

## Recalls of this device
- Mar 5, 2026 · Class II · Z-1775-2026: Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
- Oct 14, 2024 · Class II · Z-0499-2025: Devices from the affected device lots have labels that state the incorrect expiration dates.
- Oct 8, 2024 · Class II · Z-0346-2025: Affected device lots have labels that state the incorrect expiration dates.

## Indications for use
The Approach CTO Microwire Guide is intended for use in facilitating delivery of percutaneous catheters into the peripheral vasculature and is also indicated for the intraluminal placement of percutaneous catheters or other therapeutic devices beyond stenotic lesions (including chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention.

Source page: https://510kreport.com/device/K171897
Methodology: https://510kreport.com/methodology