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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, percutaneous
510(k) Number K231176
Device Name Stingray LP Catheter
Applicant
Boston Scientific
Two Scimed Place
Maple Grove,  MN  55311
Applicant Contact Gabrielle Reynolds
Correspondent
Boston Scientific
Two Scimed Place
Maple Grove,  MN  55311
Correspondent Contact Gabrielle Reynolds
Regulation Number870.1250
Classification Product Code
DQY  
Date Received04/25/2023
Decision Date 05/25/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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