FDA Product Code PQH: Iodinated Contrast Media Transfer Tubing Set
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.
Leading manufacturers include Bayer U.S., LLC, Liebel-Flarsheim Company, LLC and Bayer Medical Care, Inc..
6
Total
6
Cleared
221d
Avg days
2014
Since
Growing category -
1 submissions in the last 2 years
vs 0 in the prior period
Consistent review times:
203d avg (recent)
FDA 510(k) Cleared Iodinated Contrast Media Transfer Tubing Set Devices (Product Code PQH)
6 devices
Cleared
Nov 18, 2020
Liebel-Flarsheim IBP Transfer Set
Liebel-Flarsheim Company, LLC
General Hospital
386d
Cleared
Jul 30, 2020
MEDRAD Imaging Bulk Package Transfer Spike
Bayer Medical Care, Inc.
General Hospital
177d
Cleared
May 04, 2018
MEDRAD® Imaging Bulk Package Transfer Set
Bayer U.S., LLC
General Hospital
133d
About Product Code PQH - Regulatory Context
510(k) Submission Activity
6 total 510(k) submissions under product code PQH since 2014, with 6 receiving FDA clearance (average review time: 221 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - PQH Product Code
FDA review times for PQH submissions have been consistent, averaging 203 days recently vs 225 days historically.
PQH devices are reviewed by the General Hospital panel. Browse all General Hospital devices →