The following data is part of a premarket notification filed by Bracco Injeneering S.a. with the FDA for Bracco Injeenering Transfer Set.
| Device ID | K133147 |
| 510k Number | K133147 |
| Device Name: | BRACCO INJEENERING TRANSFER SET |
| Classification | Iodinated Contrast Media Transfer Tubing Set |
| Applicant | BRACCO INJENEERING S.A. P O BOX 3018 Nederland, CO 80466 |
| Contact | Thomas Kroenke |
| Correspondent | Thomas Kroenke BRACCO INJENEERING S.A. P O BOX 3018 Nederland, CO 80466 |
| Product Code | PQH |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2013-10-17 |
| Decision Date | 2014-06-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 37630039300358 | K133147 | 000 |