# K063695: Runthrough NS

- Pathway: 510(k) (Special)
- Applicant: Terumo Medical Corp.
- Decided: Apr 27, 2007 after 135 days
- Product code: DQX (Wire, Guide, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1330
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K953533 (1995). 2 ancestors in all.
31 later devices descend from it; 3 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961445: Radifocus Glidewire for Coronary Use with Platinum (or Gold) Coil, Terumo Medical Corp. (1996) Summary page 1.

## Most influential descendants
- K103101: HI-Torque Balance Middleweight Elite (2011), 13 descendants of its own
- K080863: Traxcess 0.014 Hydrophilic Guidewire (2008), 12 descendants of its own
- K133725: Traxcess 14 Guidewire (2014), 9 descendants of its own
- K112957: HI-Torque Powerturn (2011), 7 descendants of its own
- K122573: HI-Torque Command Guide Wire Family (2012), 6 descendants of its own

## Recalls of this device
- Jun 3, 2011 · Not classified · Z-2858-2011: Baloon catheter guidewires may become uncoiled during angioplasty procedures.

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

Source page: https://510kreport.com/device/K063695
Methodology: https://510kreport.com/methodology