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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Continuous Flush
510(k) Number K191305
Device Name Hereaeus Poseidon Microcatheter
Applicant
Heraeus Medical Components, LLC
2605 Fernbrook Lane N., Suite J
Plymouth,  MN  55447
Applicant Contact Chelsea Pioske
Correspondent
Heraeus Medical Components, LLC
2605 Fernbrook Lane N., Suite J
Plymouth,  MN  55447
Correspondent Contact Dustin Andrist
Regulation Number870.1210
Classification Product Code
KRA  
Subsequent Product Code
DQY  
Date Received05/14/2019
Decision Date 12/19/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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