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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wire, Guide, Catheter
510(k) Number K191502
Device Name Heraeus Peripheral Guidewire
Applicant
Heraeus Medical Components, LLC
2605 Fernbrook Ln. N., Suite J
Plymouth,  MN  55447
Applicant Contact Chelsea Pioske
Correspondent
Heraeus Medical Components, LLC
2605 Fernbrook Ln. N., Suite J
Plymouth,  MN  55447
Correspondent Contact Chelsea Pioske
Regulation Number870.1330
Classification Product Code
DQX  
Date Received06/06/2019
Decision Date 11/26/2019
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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