# K971254: Transend EX Platinum Guidewire

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Jul 1, 1997 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
No predicates in its family tree.
39 later devices descend from it; 9 cite it directly.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) BSC Transend EX Steerable Guidewire: named in the summary without a submission number
- (no number) BSC Preceder Guidewire: named in the summary without a submission number
- (no number) Terumo Corporation’s Glidewire Gold Guidewire: named in the summary without a submission number

## Most influential descendants
- K080863: Traxcess 0.014 Hydrophilic Guidewire (2008), 12 descendants of its own
- K110584: Asahi Chikai Neurovascular Guide Wire (2011), 11 descendants of its own
- K050964: PV 1900 Synchro 0.016 Guidewire (2005), 10 descendants of its own
- K133725: Traxcess 14 Guidewire (2014), 9 descendants of its own
- K053268: PVS 2000 SYNCHRO2 Guidewire (2006), 9 descendants of its own

## Indications for use
The Transend EX Platinum Guidewire is intended for general intravascular use, including the neuro and peripheral vasculature. The wire can be torqued to facilitate the selective placement of diagnostic or therapeutic catheters. This device is not intended for use in coronary arteries. A torque device (pin vise) is included with the wire to facilitate directional manipulation of the guidewire. A guidewire introducer is included with each wire to facilitate the introduction of the guidewire into catheter hubs or hemostatic valves.

Source page: https://510kreport.com/device/K971254
Methodology: https://510kreport.com/methodology