510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
PQHClass II

Iodinated Contrast Media Transfer Tubing Set

21 CFR 880.5440 / General Hospital
FDA source (opens on fda.gov)

PQH is the FDA product code for Iodinated Contrast Media Transfer Tubing Set, a class II device type, regulated under 21 CFR 880.5440. FDA's definition for this code reads: "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...". As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
PQH
Device name
Iodinated Contrast Media Transfer Tubing Set
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.
Regulation
21 CFR 880.5440
Device class
Class II
Review panel
General Hospital
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
6
Ingested recalls
0

Clearances, product code PQH

By decision year
6 clearances under product code PQH with a decision year between 2014 and 2026, 2020 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code PQH by decision year
YearClearances
20141
20161
20181
20202
20261

Applicants with the most clearances

Product code PQH
Applicants holding the most 510(k) clearances under product code PQH
ApplicantClearances
Medrad, Inc.2
Bayer U.S., LLC1
Bracco Injeneering S.A.1
Mallinckrodt, Inc.1
Ulrich GmbH & Co. KG1

Companies listing this code with FDA

Companies whose registered establishments list this code