PQH
6 FDA 510(k) clearances · Product code
203 daysmedian time to decision
386 days90th percentile
6clearances measured
FDA profile
- Official device name
- Iodinated Contrast Media Transfer Tubing Set
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5440
- Medical specialty
- General Hospital
- FDA 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.
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| Record | Firm | Date |
|---|---|---|
| MEDRAD® Imaging Bulk Package Transfer Spike (K253688) | Bayer Medical Care, Inc. | 2026-06-12 |
| Liebel-Flarsheim IBP Transfer Set (K193010) | Liebel-Flarsheim Company, LLC | 2020-11-18 |
| MEDRAD Imaging Bulk Package Transfer Spike (K200280) | Bayer Medical Care, Inc. | 2020-07-30 |
| MEDRAD® Imaging Bulk Package Transfer Set (K173913) | Bayer U.S., LLC | 2018-05-04 |
| ulrich Transfer Set (K161723) | Ulrich GmbH & Co. KG | 2016-12-21 |
| BRACCO INJEENERING TRANSFER SET (K133147) | Bracco Injeneering S.A. | 2014-06-20 |
Track PQH automatically
Every clearance here is in the API, with alerts when new ones post.