# K143587: ChoICE Guide Wire, Mailman Guide Wire, Luge Guide Wire, ChoICE PT Guide Wire, PT Graphix Wire

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corporation
- Decided: Jan 15, 2015 after 28 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: 4 generations back to K913353 (1991). 20 ancestors in all.
6 later devices descend from it; 4 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030617: PT2 Guide Wire and Addwire Extension Wire, Boston Scientific Scimed, Inc. (2003) Summary page 4.

## Most influential descendants
- K152231: Hornet Guidewire, Hornet 10 Guidewire, Hornet 14 Guidewire (2016), 2 descendants of its own
- K193194: CrossTorq 14 Guidewire (2019), 0 descendants of its own
- K180726: Savion DLVR Guidewire, Savion FLX Guidewire (2018), 0 descendants of its own
- K180795: JUDO 1 Guidewire, JUDO 3 Guidewire, JUDO 6 Guidewire (2018), 0 descendants of its own
- K170532: True Form Reshapable Guide Wire (2017), 0 descendants of its own

## Recalls of this device
- Mar 28, 2016 · Class II · Z-1370-2016: Boston Scientific is voluntarily implementing a Medical Device Recall of one batch of PT Graphix Magnet J-TIP Guidewires. Boston Scientific has found that, while the batch is labeled as a J-tip model,

## Indications for use
Boston Scientific ChoICE™ PT, PT Graphix™, ChoICE, Luge, and Mailman Guidewires with ICE Hydrophilic Coating are intended to facilitate the placement of balloon dilatation catheters or other therapeutic devices during PTCA or other intravascular interventional procedures. They are not intended for use in the cerebral vasculature. Boston Scientific ChoICE™ PT Magnet, PT Graphix™ Magnet, ChoICE Magnet, Luge Magnet, and Mailman Magnet Guidewires with ICE Hydrophilic Coating are intended to facilitate the placement of balloon dilatation catheters or other therapeutic devices during PTCA or other intravascular interventional procedures. They are not intended for use in the cerebral vasculature.

Source page: https://510kreport.com/device/K143587
Methodology: https://510kreport.com/methodology