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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, intravascular, diagnostic
510(k) Number K221470
Device Name Langston dual lumen catheter
Applicant
Vascular Solutions LLC
6464 Sycamore Court North
Minneapolis,  MN  55369
Applicant Contact Becky Astrup
Correspondent
Vascular Solutions LLC
6464 Sycamore Court North
Minneapolis,  MN  55369
Correspondent Contact Becky Astrup
Regulation Number870.1200
Classification Product Code
DQO  
Date Received05/20/2022
Decision Date 06/17/2022
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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