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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 K243193
Device Name Cross Wise™ Multi-Use RF Adapter Cable
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 Received09/30/2024
Decision Date 11/26/2024
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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