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510(k) K163508

PIVO by Velano Vascular — Product Code JKA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 9, 2017
Date Received
December 14, 2016
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubes, Vials, Systems, Serum Separators, Blood Collection
Device Class
Class II
Regulation Number
862.1675
Review Panel
CH
Submission Type

Other clearances by Velano Vascular

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  • K193569 — PIVO(TM) (January 21, 2020)
  • K190604 — PIVO (May 13, 2019)
  • K182897 — Velano Vascular Q2 Extension Set (March 26, 2019)
  • K152924 — TIVA¿ (January 7, 2016)
  • K142946 — TIVA (January 8, 2015)

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