# K132545: Medivalve Acwire

- Pathway: 510(k) (Traditional)
- Applicant: Medivalve, Ltd.
- Decided: Nov 8, 2013 after 87 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: 5 generations back to K970376 (1997). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062192: Ostial Pro Stent Positioning System, Ostial Solutions, LLC (2007)

## Cited in the summary but kept off the family tree
- K001084: Trans FX Adjustable Pin to Bar Clamp, Immedica, Inc. (2000). Our reading of the summary gave K001084, FDA’s number for Trans FX Adjustable Pin to Bar Clamp (Immedica, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Lake Region Manufacturing (LRM) Catheter Guidewire”. Kept off the family tree.

## Indications for use
The acWire is intended for use in peripheral vascular and heart catheterization procedures to introduce and assist in positioning diagnostic and interventional devices. The acWire may also function as an alignment tool by providing a reference plane of anatomical structures of interest (e.g., the aortic valve).

Source page: https://510kreport.com/device/K132545
Methodology: https://510kreport.com/methodology