# K100710: Roll-X Guidewire

- Pathway: 510(k) (Traditional)
- Applicant: St Jude Medical
- Decided: Apr 28, 2010 after 47 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: 8 generations back to K890505 (1989). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082304: Roll-X Guidewire, St Jude Medical (2008) Summary page 1.
- K052339: Asahi Ptca Guide Wire, Asahi Intecc Co., Ltd. (2005) Summary page 1.
- K013833: HI-Toque Balance Middleweight Universal Guide Wire with Hydrocoat Hydrophilic Coating, #1009659,1009659J, 1009660, 10096, Guidant Corp. (2002)
- K982083: Acs HI-Torque Balance Heavyweight Guide Wire with Hydrocoat Hydrophilic Coating, Guidant Corp. (1998) Summary page 1.

## Indications for use
Roll-X Guidewires are intended to facilitate the placement of balloon dilation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The wires are also intended to facilitate the placement of compatible interventional devices during therapeutic intravascular procedures. The guidewires are not to be used in cerebral blood vessels.

Source page: https://510kreport.com/device/K100710
Methodology: https://510kreport.com/methodology