MEDRAD® Imaging Bulk Package Transfer Set

Iodinated Contrast Media Transfer Tubing Set

Bayer U.S. LLC

The following data is part of a premarket notification filed by Bayer U.s. Llc with the FDA for Medrad® Imaging Bulk Package Transfer Set.

Pre-market Notification Details

• Device ID: K173913
• 510k Number: K173913
• Device Name: MEDRAD® Imaging Bulk Package Transfer Set
• Classification: Iodinated Contrast Media Transfer Tubing Set
• Applicant: Bayer U.S. LLC 1 Bayer Drive Indianola, PA 15051
• Contact: Leslie S. O'nan
• Correspondent: Leslie S. O'nan; Bayer U.S. LLC 1 Bayer Drive Indianola, PA 15051
• Product Code: PQH
• CFR Regulation Number: 880.5440 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-12-22
• Decision Date: 2018-05-04
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
40616258008194	K173913	000