Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
K200280Substantially Equivalent

MEDRAD Imaging Bulk Package Transfer Spike

Medrad, Inc., Indianaola PA / Traditional, Substantially Equivalent

K200280 is the FDA 510(k) clearance record for MEDRAD Imaging Bulk Package Transfer Spike, a class II device, cleared for Bayer Medical Care, Inc. on under FDA product code PQH (Iodinated Contrast Media Transfer Tubing Set). FDA's definition for product code PQH 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...". FDA records list 177 510(k) clearances for Medrad, Inc., from to . As of , FDA records show no recalls naming K200280.

Clearance record

Decision date
Received
(177 days to decision)
Product code
PQH Iodinated Contrast Media Transfer Tubing Set
Regulation
21 CFR 880.5440
Device class
Class II
Review panel
General Hospital
Applicant
Bayer Medical Care, Inc. 1 Bayer Dr., Indianaola PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PQH

Trailing 12 months
1 clearance under product code PQH in the twelve months to October 2026, June 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code PQH, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260