# K171445: Amplatz Support Wire Guide with Apex Curve

- Pathway: 510(k) (Traditional)
- Applicant: Cook Incorporated
- Decided: Jan 10, 2018 after 239 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: 4 generations back to K930622 (1993). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153397: S-Wire Guidewire System, Concert Medical, LLC (2016) Summary page 4.

## Indications for use
The Amplatz Support Wire Guide with Apex Curve is used to facilitate the placement of devices during diagnostic and interventional procedures. The Amplatz Support Wire Guide with Apex Curve is intended to facilitate the introduction and placement of interventional devices within the chambers of the heart including those used within trans-catheter aortic valve procedures.

Source page: https://510kreport.com/device/K171445
Methodology: https://510kreport.com/methodology