The following data is part of a premarket notification filed by Coeur, Inc. with the FDA for Disposable Torque Device.
| Device ID | K113498 |
| 510k Number | K113498 |
| Device Name: | DISPOSABLE TORQUE DEVICE |
| Classification | Wire, Guide, Catheter |
| Applicant | COEUR, INC. 100 PHYSICIANS WAY SUITE 200 Lebanon, TN 37090 |
| Contact | Debra F Manning |
| Correspondent | Debra F Manning COEUR, INC. 100 PHYSICIANS WAY SUITE 200 Lebanon, TN 37090 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-25 |
| Decision Date | 2012-07-20 |