# K011986: Safe-Steer Guide Wire System

- Pathway: 510(k) (Traditional)
- Applicant: Intra Luminal Therapeutics, Inc.
- Decided: Apr 3, 2002 after 281 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: 3 generations back to K890505 (1989). 7 ancestors in all.
76 later devices descend from it; 1 cites it directly.
0 of 84 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981381: Acs HI-Torque Cross-IT Guide Wire with Hydrocoat Hydrophilic Coating Product Family Models 1003211H,1003212HJ,1003213H,1, Guidant Corp. (1998). Our OCR of the scanned summary read K881381, FDA’s number for Reagents for TSH Assay (Sclavo, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “ACS Hi-Torque Cross-it Guide Wire”.
- K990639: Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with Hydrocoat Hydrophilic Coating., Guidant Corp. (1999) Summary page 1.
- K881897: Acs HI-Torque Floppy/Floppy II/Inter./Standard GW, Advanced Cardiovascular Systems, Inc. (1988) Summary page 1.
- K881787: Acs HI-Torque Standard & Intermedi. Guide Wire, Advanced Cardiovascular Systems, Inc. (1988) Summary page 1.

## Most influential descendants
- K021323: Modification to Safe-Steer Guide Wire System (2002), 75 descendants of its own
- K031842: Safe-Cross Radio Frequency Total Occlusion Crossing System (2003), 40 descendants of its own
- K040067: Clirpath Excimer Laser Catheter (2004), 36 descendants of its own
- K032031: Safe-Cross Radio Frequency Total Occlusion Crossing System (2004), 36 descendants of its own
- K062868: The Crosser Catheter, Model CR1100 and System Electronics, Model FG1002-02 (2007), 31 descendants of its own

## Indications for use
The Safe-Steer™ Guide Wire System is indicated for use in facilitating the placement of catheters used in percutaneous interventions in native coronary arteries with total occlusions.

Source page: https://510kreport.com/device/K011986
Methodology: https://510kreport.com/methodology