PQH
- Product code
- PQH
- Device name
- Iodinated Contrast Media Transfer Tubing Set
- Device class
- Class 2
- 21 CFR
- 21 CFR 880.5440
- Medical specialty
- General Hospital
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 1
- Summaries archived here
- 1 (direct download)
- 510(k) clearances (all years, FDA)
- 6 (all years; only the last 3 years are listed here)
FDA classification 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.
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253688 | 2026-06-12 | Bayer Medical Care, Inc. | MEDRAD® Imaging Bulk Package Transfer Spike |
Official FDA classification page: PQH
Classification and pathway per current FDA publications. Data from openFDA (CC0).