The following data is part of a premarket notification filed by Bracco Injeneering with the FDA for Ct Expres 3d Contrast Media Delivery System, Bottle Spike Type B, Day Set Iii Hp, Patient Set.
| Device ID | K151048 |
| 510k Number | K151048 |
| Device Name: | CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B, Day Set III HP, Patient Set |
| Classification | Injector, Contrast Medium, Automatic |
| Applicant | BRACCO INJENEERING AVENUE DE SEVELIN 46 Lausanne, CH Ch-1004 |
| Contact | Maud Giorgi |
| Correspondent | Cynthia Nolte ICON Clinical Research LLC 62 FOREST STREET SUITE 300 Marlborough, MA 01752 |
| Product Code | IZQ |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2015-04-20 |
| Decision Date | 2016-01-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 47630039300096 | K151048 | 000 |
| 37630039301881 | K151048 | 000 |
| 37630039301218 | K151048 | 000 |
| 37630039301317 | K151048 | 000 |
| 37630039301492 | K151048 | 000 |
| 37630039301577 | K151048 | 000 |
| 37630039300006 | K151048 | 000 |
| 37630039300013 | K151048 | 000 |
| 37630039300020 | K151048 | 000 |
| 37630039300105 | K151048 | 000 |
| 37630039300112 | K151048 | 000 |
| 37630039300143 | K151048 | 000 |
| 17630039300156 | K151048 | 000 |
| 17630039300200 | K151048 | 000 |
| 37630039301713 | K151048 | 000 |