K200280 is an FDA 510(k) clearance for the MEDRAD Imaging Bulk Package Transfer Spike. This device is classified as a Iodinated Contrast Media Transfer Tubing Set (Class II - Special Controls, product code PQH).
Submitted by Bayer Medical Care, Inc. (Indianaola, US). The FDA issued a Cleared decision on July 30, 2020, 177 days after receiving the submission on February 4, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440. The Iodinated Contrast Media Transfer Set Is Intended To Transfer Iodinated Contrast Media From Imaging Bulk Package Contrast Media In A Controlled Ambient Environment. The Transfer Set Is Intended To Be Used To Directly Fill Multiple Sterile Single Use Syringes From An Imaging Bulk Package Contrast Media Bulk Package Under Controlled Ambient Filling Conditions Such As A Ct Suite..
| 510(k) Number | K200280 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 04, 2020 |
| Decision Date | July 30, 2020 |
| Days to Decision | 177 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | PQH - Iodinated Contrast Media Transfer Tubing Set |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |
| Definition | The Iodinated Contrast Media Transfer Set Is Intended To Transfer Iodinated Contrast Media From Imaging Bulk Package Contrast Media In A Controlled Ambient Environment. The Transfer Set Is Intended To Be Used To Directly Fill Multiple Sterile Single Use Syringes From An Imaging Bulk Package Contrast Media Bulk Package Under Controlled Ambient Filling Conditions Such As A Ct Suite. |