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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Iodinated Contrast Media Transfer Tubing Set
510(k) Number K253688
Device Name MEDRAD® Imaging Bulk Package Transfer Spike
Applicant
Bayer Medical Care, Inc.
1 Bayer Dr.
Indianaola,  PA  15051
Applicant Contact Troy Jack
Correspondent
Bayer Medical Care, Inc.
1 Bayer Dr.
Indianaola,  PA  15051
Correspondent Contact Nishanth Reddy Deva
Regulation Number880.5440
Classification Product Code
PQH  
Date Received11/21/2025
Decision Date 06/12/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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