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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Steerable
510(k) Number K262165
Device Name FARADRIVE™ Steerable Sheath (M004PF21M402)
Applicant
Boston Scientific Corporation
4100 Hamline Ave. N.
Saint Paul,  MN  55112
Applicant Contact Mariafernanda Marroquin
Correspondent
Boston Scientific Corporation
4100 Hamline Ave. N.
Saint Paul,  MN  55112
Correspondent Contact Mariafernanda Marroquin
Regulation Number870.1280
Classification Product Code
DRA  
Date Received06/26/2026
Decision Date 07/24/2026
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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