# K040592: Cordis Steer-IT Deflecting Tip Guidewire

- Pathway: 510(k) (Traditional)
- Applicant: Cordis Corp.
- Decided: Dec 17, 2004 after 284 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 K970376 (1997). 7 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953760: Cordis Wizdom Steerable Guidewire, Cordis Corp. (1995) Summary page 1.
- K934474: Pilot Cardiovascular Systems 2 CM Pilot Wire, Pilot Cardiovascular Systems, Inc., Sub. C.R. Bard (1993) Summary page 2.
- K011084: Mandrel Guidewire Assembly, Lake Region Mfg., Inc. (2001) Summary page 1.
- K011968: Streerable Ptca Guidewire, Lake Region Mfg., Inc. (2001) Summary page 1.
- K881787: Acs HI-Torque Standard & Intermedi. Guide Wire, Advanced Cardiovascular Systems, Inc. (1988) Summary page 2.
- K994358: Atw Marker Wire Steerable Guidewire, Cordis Corp. (2000) Summary page 1.

## Most influential descendants
- K070212: CITOP10 Guidewire, 0.014(1.4MM Tip), CITOP6 Guidewire, 0.014(1.0MM Tip), Citop Support Accessory, 0.023(126CM) (2007), 1 descendant of its own
- K171897: Approach CTO Microwire Guide (2017), 0 descendants of its own

## Indications for use
The Cordis STEER-IT Deflecting Tip Guidewires are intended for use in angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature.

Source page: https://510kreport.com/device/K040592
Methodology: https://510kreport.com/methodology