The following data is part of a premarket notification filed by Coeur Medical with the FDA for The Coeur Injector Adaptor/pressure Jacket, Model C859-6003.
| Device ID | K032920 |
| 510k Number | K032920 |
| Device Name: | THE COEUR INJECTOR ADAPTOR/PRESSURE JACKET, MODEL C859-6003 |
| Classification | Injector And Syringe, Angiographic |
| Applicant | COEUR MEDICAL 209 CREEKSIDE DR. Washington, NC 27889 |
| Contact | Debra F Manning |
| Correspondent | Debra F Manning COEUR MEDICAL 209 CREEKSIDE DR. Washington, NC 27889 |
| Product Code | DXT |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-22 |
| Decision Date | 2003-12-16 |