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510(k) K182897

Velano Vascular Q2 Extension Set by Velano Vascular — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 26, 2019
Date Received
October 16, 2018
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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  • K163508 — PIVO (February 9, 2017)
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  • K142946 — TIVA (January 8, 2015)

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