FDA 510(k)

MEDRAD® Imaging Bulk Package Transfer Set

K-Number: K173913 · 2018-05-04

Decision Date2018-05-04

Product CodePQH

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

MEDRAD® Imaging Bulk Package Transfer Set is a medical device manufactured by Bayer U.S., LLC. It received FDA 510(k) clearance on 2018-05-04 under approval number K173913. The device is classified under product code PQH. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDRAD® Imaging Bulk Package Transfer Set?

MEDRAD® Imaging Bulk Package Transfer Set is a medical device that received FDA 510(k) clearance on 2018-05-04. It is manufactured by Bayer U.S., LLC. The 510(k) number is K173913.

When was MEDRAD® Imaging Bulk Package Transfer Set approved by the FDA?

MEDRAD® Imaging Bulk Package Transfer Set received FDA 510(k) clearance on 2018-05-04, under approval number K173913.

What company makes MEDRAD® Imaging Bulk Package Transfer Set?

MEDRAD® Imaging Bulk Package Transfer Set is manufactured by Bayer U.S., LLC.

What is the FDA product code for MEDRAD® Imaging Bulk Package Transfer Set?

The FDA product code for MEDRAD® Imaging Bulk Package Transfer Set is PQH.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.