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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 K212211
Device Name Turnpike catheter, Turnpike Spiral catheter, Turnpike LP catheter, Turnpike Gold catheter, GuideLiner V3 catheter, TrapLiner catheter
Applicant
Vascular Solutions, LLC
6464 Sycamore Ct. N.
Minneapolis,  MN  55369
Applicant Contact Rebecca Astrup
Correspondent
Vascular Solutions, LLC
6464 Sycamore Ct. N.
Minneapolis,  MN  55369
Correspondent Contact Rebecca Astrup
Regulation Number870.1250
Classification Product Code
DQY  
Date Received07/15/2021
Decision Date 02/09/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Clinical Trials NCT03988166
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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