# K110479: Acuity Whisper View Guide Wires

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corp
- Decided: Apr 8, 2011 after 49 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: 6 generations back to K002206 (2000). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061453: HI-Torque Whisper View Guide Wire, Guidant Corp. (2006) Summary page 1.
- K090554: Acuity Mailman and Strait-Trak Guidewire, Boston Scientific Corp (2009) Summary page 1.

## Indications for use
Boston Scientific ACUITY WHISPER VIEWTM Guide Wires with Hydrophilic Coating are intended to facilitate the placement of Boston Scientific or Guidant Left Ventricular (LV) leads within the coronary venous vasculature.

Source page: https://510kreport.com/device/K110479
Methodology: https://510kreport.com/methodology