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510(k) K162427

Vado Bi-Directional Steerable Sheath by Kalila Medical, Inc. — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 2017
Date Received
August 30, 2016
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

Other clearances by Kalila Medical, Inc.

  • K160721 — Vado Steerable Sheath (March 7, 2017)
  • K140420 — VADO STEERABLE SHEATH (April 1, 2014)

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