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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 K251007
Device Name CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F)
Applicant
Circa Scientific, Inc.
14 Inverness Dr. E, Suite H-136
Englewood,  CO  80112
Applicant Contact Jennifer Willner
Correspondent
JW Regulatory Consulting, LLC
406 Wacouta St., Suite 417
Saint Paul,  MN  55101
Correspondent Contact Jennifer Willner
Regulation Number870.5175
Classification Product Code
DXF  
Date Received04/01/2025
Decision Date 05/01/2025
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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