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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Introducer, Catheter
510(k) Number K260626
Device Name Multiflex Steerable Sheath 17.5F
Applicant
Vizaramed, Inc.
1914 O'Toole Way
San Jose,  CA  95131
Applicant Contact Jack Douglas
Correspondent
Vizaramed, Inc.
1914 O'Toole Way
San Jose,  CA  95131
Correspondent Contact Jack Douglas
Regulation Number870.1340
Classification Product Code
DYB  
Date Received02/26/2026
Decision Date 03/26/2026
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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