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510(k) K160721

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 7, 2017
Date Received
March 16, 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.

  • K162427 — Vado Bi-Directional Steerable Sheath (January 27, 2017)
  • K140420 — VADO STEERABLE SHEATH (April 1, 2014)

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