The following data is part of a premarket notification filed by Bayer Medical Care Inc. with the FDA for Medrad Imaging Bulk Package Transfer Spike.
| Device ID | K200280 |
| 510k Number | K200280 |
| Device Name: | MEDRAD Imaging Bulk Package Transfer Spike |
| Classification | Iodinated Contrast Media Transfer Tubing Set |
| Applicant | Bayer Medical Care Inc. 1 Bayer Drive Indianola, PA 15051 |
| Contact | Leslie S O'nan |
| Correspondent | Leslie S O'nan Bayer Medical Care Inc. 1 Bayer Drive Indianola, PA 15051 |
| Product Code | PQH |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-04 |
| Decision Date | 2020-07-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 40616258022367 | K200280 | 000 |