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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reprocessed Intravascular Ultrasound Catheter
510(k) Number K182238
Device Name Reprocessed ViewFlex Xtra ICE Catheter
Applicant
Stryker Sustainability Solutions
1810 W Dr.Ake Dr.
Tempe,  AZ  85283
Applicant Contact Ramona Kulik
Correspondent
Stryker Sustainability Solutions
1810 W Dr.Ake Dr.
Tempe,  AZ  85283
Correspondent Contact Ramona Kulik
Regulation Number870.1200
Classification Product Code
OWQ  
Date Received08/20/2018
Decision Date 05/08/2019
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
Recalls CDRH Recalls
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