Submission Details
| 510(k) Number | K040592 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 08, 2004 |
| Decision Date | December 17, 2004 |
| Days to Decision | 284 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
CORDIS STEER-IT DEFLECTING TIP GUIDEWIRE
Dec 2004
Decision
284d
Days
Class 2
Risk
About This 510(k) Submission
K040592 is an FDA 510(k) clearance for the CORDIS STEER-IT DEFLECTING TIP GUIDEWIRE, a Wire, Guide, Catheter (Class II — Special Controls, product code DQX), submitted by Cordis Corp. (Miami Lakes, US). The FDA issued a Cleared decision on December 17, 2004, 284 days after receiving the submission on March 8, 2004. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1330.
Device Classification
| Product Code | DQX — Wire, Guide, Catheter |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.1330 |
Manufacturer
Similar Devices — DQX Wire, Guide, Catheter
All 760
K253262 · Nano4imaging GmbH
· Mar 2026
K253847 · Merit Medical Ireland, Ltd.
· Jan 2026
K251385 · Merit Medical Ireland, Ltd.
· Jan 2026
K252674 · Solo Pace, Inc.
· Jan 2026
K251596 · William Cook Europe Aps
· Nov 2025
K250203 · Sureax Medical, LLC
· Oct 2025
More from Cordis Corp.
View all
K130981
· FGE · Mar 2014
K112797
· LIT · May 2012
K101651
· NTE · Jul 2010
K082143
· PDU · Aug 2008
K062798
· FGE · Feb 2008