PQH

Iodinated Contrast Media Transfer Tubing Set

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2026-06-12.

NumberDecision dateApplicantDevice nameSummary
K2536882026-06-12Bayer Medical Care, Inc.MEDRAD® Imaging Bulk Package Transfer SpikePDF

1 summaries are archived here for direct download.

Official FDA classification page: PQH
Classification and pathway per current FDA publications. Data from openFDA (CC0).