# K090554: Acuity Mailman and Strait-Trak Guidewire

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Jul 2, 2009 after 122 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: 5 generations back to K002206 (2000). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964551: Choice Super Support Ptca Guide Wire, Choice Plus Super Support Ptca Guide Wire, Choice Exchange Super Support Ptca Guid, Scimed Life Systems, Inc. (1997) Summary page 1.
- K061453: HI-Torque Whisper View Guide Wire, Guidant Corp. (2006) Summary page 1.

## Most influential descendants
- K110479: Acuity Whisper View Guide Wires (2011), 0 descendants of its own

## Indications for use
Boston Scientific ACUITY Strait-Trak and ACUITY Mailman Venous Guidewires are intended to facilitate the placement of Boston Scientific or Guidant Left Ventricular (LV) leads within the Coronary Sinus (CS) vasculature.

Source page: https://510kreport.com/device/K090554
Methodology: https://510kreport.com/methodology