Submission Details
| 510(k) Number | K113498 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 25, 2011 |
| Decision Date | July 20, 2012 |
| Days to Decision | 238 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
Cleared
Traditional
DISPOSABLE TORQUE DEVICE
Jul 2012
Decision
238d
Days
Class 2
Risk
About This 510(k) Submission
K113498 is an FDA 510(k) clearance for the DISPOSABLE TORQUE DEVICE, a Wire, Guide, Catheter (Class II — Special Controls, product code DQX), submitted by Coeur, Inc. (Lebanon, US). The FDA issued a Cleared decision on July 20, 2012, 238 days after receiving the submission on November 25, 2011. 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 Coeur, Inc.
View all
K170431
· DXT · Aug 2017
K161471
· DXT · Oct 2016
K150902
· DXT · Oct 2015
K142745
· DXT · Apr 2015
K140469
· DXT · Jul 2014