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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 K214106
Device Name QuikPass Catheter
Applicant
Traverse Vascular, Inc.
535 Stevens Ave. W.
Solana Beach,  CA  92075
Applicant Contact Greg Geissinger
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number870.1250
Classification Product Code
DQY  
Date Received12/29/2021
Decision Date 01/28/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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