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510(k) K233248

FARADRIVE™ Steerable Sheath by Boston Scientific Corporation — Product Code DRA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 2023
Date Received
September 28, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Steerable
Device Class
Class II
Regulation Number
870.1280
Review Panel
CV
Submission Type

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