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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 K240900
Device Name HOTWIRE™ RF Guidewire
Applicant
Atraverse Medical
2611 S Coast Hwy 101 #204
Cardiff By The Sea,  CA  92007
Applicant Contact Charles Yang
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number870.5175
Classification Product Code
DXF  
Date Received04/01/2024
Decision Date 05/01/2024
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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