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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, septostomy
510(k) Number K232852
Device Name Cross Vascular RF Transseptal Needle, Cross Vascular Connection Cable
Applicant
Cross Vascular Inc.
535 Stevens Ave West
Solana Beach,  CA  92075
Applicant Contact Jennifer Willner
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number870.5175
Classification Product Code
DXF  
Date Received09/14/2023
Decision Date 10/12/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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