# K964611: Transend Guidewire

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Jan 28, 1997 after 71 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.
2 later devices descend from it; 2 cite it directly.
0 of 3 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 Guidewire: named in the summary without a submission number
- (no number) Target Therapeutics Dasher-10 and Seeker-Lite Guidewires: named in the summary without a submission number
- (no number) Terumo Corporation’s Glidewire Gold Guidewire: named in the summary without a submission number
- (no number) Micro Interventional Systems Quicksilver Guidewire: named in the summary without a submission number

## Most influential descendants
- K113454: 14 Wire Standard, 14 Wire LS (2012), 0 descendants of its own
- K023700: PVS 1600 Synchro 0.010 Neuro Guide Wire (2002), 0 descendants of its own

## Indications for use
The BSC Transend Steerable Guidewire with hydrophilic coating and accessories are intended for general intravascular use including the peripheral and neurovasculature. The devices will be provided sterile, and are intended for one procedure use only.

Source page: https://510kreport.com/device/K964611
Methodology: https://510kreport.com/methodology