# K082304: Roll-X Guidewire

- Pathway: 510(k) (Traditional)
- Applicant: St Jude Medical
- Decided: Aug 27, 2008 after 14 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: 7 generations back to K890505 (1989). 17 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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) Summary page 1.

## Most influential descendants
- K101729: Neowire Pta/Ptca Guidewire (2010), 0 descendants of its own
- K100710: Roll-X Guidewire (2010), 0 descendants of its own

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

Source page: https://510kreport.com/device/K082304
Methodology: https://510kreport.com/methodology