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510(k) K220414

VersaCross Connect Transseptal Dilator by Baylis Medical Company, Inc. — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 2022
Date Received
February 14, 2022
Clearance Type
Special
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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  • K191546 — Epicardial Access System (August 2, 2019)
  • K183632 — Diagnostic Fixed Electrophysiology Lumen Catheter , Diagnostic Electrophysiology (June 7, 2019)

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