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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Ultrasound, Intravascular
510(k) Number K261696
Device Name ACUNAV Luxera 4D ICE Catheter
Applicant
Siemens Medical Solutions USA, Inc.
22010 S. E. 51st St.
Issaquah,  WA  98029
Applicant Contact Bongsoo Cho
Correspondent
Siemens Medical Solutions USA, Inc.
22010 S. E. 51st St.
Issaquah,  WA  98029
Correspondent Contact Bongsoo Cho
Regulation Number870.1200
Classification Product Code
OBJ  
Date Received05/22/2026
Decision Date 09/10/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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