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510(k) K231227

SureFlex HD Steerable Sheath, VersaCross HD Steerable Sheath by Baylis Medical Company, Inc. — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 2023
Date Received
April 28, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Introducer, Catheter
Device Class
Class II
Regulation Number
870.1340
Review Panel
CV
Submission Type

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