# K061171: Sequitor Steerable Guidewire, Models SQR18XX and SQR14XX

- Pathway: 510(k) (Traditional)
- Applicant: Biosphere Medical, Inc.
- Decided: Jun 2, 2006 after 36 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: 2 generations back to K950113 (1995). 5 ancestors in all.
36 later devices descend from it; 1 cites it directly.
5 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011287: Radius Cougar Wire, Radius Medical Technologies, Inc. (2001)
- K032129: Radius 018 Cougar Wire, Radius Medical Technologies, Inc. (2003) Summary page 1.
- K022357: Transend 300 ES Guidewire, Model 46-814 & Transend 300 Floppy Guidewire, Model 46-815, Boston Scientific, Target (2002) Summary page 1.

## Most influential descendants
- 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
- K091781: Guided Medical Positioning System (GMPS) (2009), 11 descendants of its own

## Indications for use
The Sequitor™ Steerable Guidewire is intended to facilitate the placement of catheters within the peripheral vasculature for various diagnostic and interventional procedures.

Source page: https://510kreport.com/device/K061171
Methodology: https://510kreport.com/methodology