PQH — Iodinated Contrast Media Transfer Tubing Set Class II
Classification Details
- Product Code
- PQH
- Device Class
- Class II
- Regulation Number
- 880.5440
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K193010 | liebel-flarsheim company | Liebel-Flarsheim IBP Transfer Set | November 18, 2020 |
| K200280 | bayer medical care | MEDRAD Imaging Bulk Package Transfer Spike | July 30, 2020 |
| K173913 | bayer u.s | MEDRAD® Imaging Bulk Package Transfer Set | May 4, 2018 |
| K161723 | ulrich gmbh and co. kg | ulrich Transfer Set | December 21, 2016 |
| K133147 | bracco injeneering | BRACCO INJEENERING TRANSFER SET | June 20, 2014 |