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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 K220647
Device Name GuideLiner Coast, 5.5F (5270); GuideLiner Coast, 6F (5271); GuideLiner Coast, 7F (5272); GuideLiner Coast, 8F (5273)
Applicant
Vascular Solutions, LLC
6464 Sycamore Court N
Maple Grove,  MN  55369
Applicant Contact Steph Pahl
Correspondent
Vascular Solutions, LLC
6464 Sycamore Court N
Maple Grove,  MN  55369
Correspondent Contact Steph Pahl
Regulation Number870.1250
Classification Product Code
DQY  
Date Received03/07/2022
Decision Date 08/18/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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