The following data is part of a premarket notification filed by Coeur, Inc. with the FDA for Disposable 330psi Extension Lines.
| Device ID | K120892 |
| 510k Number | K120892 |
| Device Name: | DISPOSABLE 330PSI EXTENSION LINES |
| Classification | Injector And Syringe, Angiographic |
| 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 | DXT |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-23 |
| Decision Date | 2013-06-10 |