PQH — Iodinated Contrast Media Transfer Tubing Set Class II
FDA product code PQH covers "Iodinated Contrast Media Transfer Tubing Set", a Class II medical device regulated under 21 CFR 880.5440. Submissions are reviewed by the General Hospital panel. At least 6 recent 510(k) clearances have been granted under this product code.
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 |
|---|---|---|---|
| K253688 | bayer medical care | MEDRAD® Imaging Bulk Package Transfer Spike | June 12, 2026 |
| 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 |