K161723 is an FDA 510(k) clearance for the ulrich Transfer Set. This device is classified as a Iodinated Contrast Media Transfer Tubing Set (Class II - Special Controls, product code PQH).
Submitted by Ulrich GmbH & Co. KG (Ulm, DE). The FDA issued a Cleared decision on December 21, 2016, 182 days after receiving the submission on June 22, 2016.
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 | K161723 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 22, 2016 |
| Decision Date | December 21, 2016 |
| Days to Decision | 182 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. |