# K022357: Transend 300 ES Guidewire, Model 46-814 & Transend 300 Floppy Guidewire, Model 46-815

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific, Target
- Decided: Oct 16, 2002 after 89 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: 1 generation back to K950113 (1995). 2 ancestors in all.
38 later devices descend from it; 2 cite it directly.
5 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K950069: Dasher-14, Target Therapeutics (1995) Summary page 1.
- K950113: Scimed (R) Chice (TM) Exchange Ptca Guide Wire, Scimed Life Systems, Inc. (1995) Summary page 1.

## Most influential descendants
- K061171: Sequitor Steerable Guidewire, Models SQR18XX and SQR14XX (2006), 36 descendants of its own
- K062192: Ostial Pro Stent Positioning System (2007), 35 descendants of its own
- K083745: The IC-Pro System, Model Version 3.2 (2009), 30 descendants of its own
- K110256: The IC-Pro System (2011), 15 descendants of its own
- K100292: Caas Qva 3D, Caas Qca 3D (2010), 13 descendants of its own

## Indications for use
The TransendTM300 ES Guidewire and TransendTM300 Floppy Guidewire are intended for general intravascular use, including the neuro and peripheral vasculature. The guidewires can be torqued to facilitate the selective placement of diagnostic or therapeutic catheters. These devices are not intended for use in coronary arteries. A torque device (pin vise) is included to facilitate directional manipulation of the guidewires.

Source page: https://510kreport.com/device/K022357
Methodology: https://510kreport.com/methodology