# K080563: Runthrough NS Extension Wire

- Pathway: 510(k) (Special)
- Applicant: Terumo Medical Corp.
- Decided: Mar 20, 2008 after 21 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: 3 generations back to K953533 (1995). 3 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063695: Runthrough NS, Terumo Medical Corp. (2007) Summary page 1.

## Most influential descendants
- K093647: Traxcess Docking Wire (2010), 2 descendants of its own
- K112219: Tapas Catheter (2011), 1 descendant of its own
- K093397: Traxcess 14EX Guidewire and Traxcess Docking Wire (2009), 1 descendant of its own
- K191687: pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire (2019), 0 descendants of its own
- K141175: Renovocath RC120 (2014), 0 descendants of its own

## Indications for use
The Runthrough NS Extension Wire are used to facilitate the placement of balloon dilatation catheters for percutaneous transluminal coronary angioplasty (PTCA) and/or percutaneous transluminal angioplasty (PTA).

Source page: https://510kreport.com/device/K080563
Methodology: https://510kreport.com/methodology