West Gets FDA 510(k) Clearance for Vial2Bag Advanced 13mm Admixture Device
December 04 2023 - 2:46PM
Dow Jones News
By Stephen Nakrosis
West Pharmaceutical Services said Monday the U.S. Food and Drug
Administration gave 510(k) clearance for the launch of the Vial2Bag
Advanced 13mm admixture device.
West Pharmaceutical said its Vial2Bag Advanced 13mm admixture
device can serve to connect various IV bags and vials to an
external IV administration set. "The integrated vial adapter makes
it possible to reconstitute and/or admix drugs prior to
administration to the patient," the company said.
Section 510(k) of the Food, Drug and Cosmetic Act requires
manufacturers to give the FDA 90 days advance notice before they
can market a medical device.
Write to Stephen Nakrosis at stephen.nakrosis@wsj.com
(END) Dow Jones Newswires
December 04, 2023 15:31 ET (20:31 GMT)
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