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510(k) K200439

Velano ExT Extension Set by Velano Vascular — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 23, 2021
Date Received
February 24, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, Intravascular
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

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  • K182897 — Velano Vascular Q2 Extension Set (March 26, 2019)
  • K163508 — PIVO (February 9, 2017)
  • K152924 — TIVA¿ (January 7, 2016)
  • K142946 — TIVA (January 8, 2015)

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