The following data is part of a premarket notification filed by Coeur Laboratories, Inc. with the FDA for Coeur Front Load Injector Retrofit Kit (c859-0002).
| Device ID | K965214 |
| 510k Number | K965214 |
| Device Name: | COEUR FRONT LOAD INJECTOR RETROFIT KIT (C859-0002) |
| Classification | Gas Control Unit, Cardiopulmonary Bypass |
| Applicant | COEUR LABORATORIES, INC. 5301 DEPATURE DR. Raleigh, NC 27604 |
| Contact | James M Clinton |
| Correspondent | James M Clinton COEUR LABORATORIES, INC. 5301 DEPATURE DR. Raleigh, NC 27604 |
| Product Code | DTX |
| CFR Regulation Number | 870.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-30 |
| Decision Date | 1997-03-28 |
| Summary: | summary |