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510(k) K190604

PIVO by Velano Vascular — Product Code JKA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 13, 2019
Date Received
March 8, 2019
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

  • K201237 — Velano Vascular Blood Collection Adapter (October 3, 2022)
  • K200439 — Velano ExT Extension Set (February 23, 2021)
  • K193569 — PIVO(TM) (January 21, 2020)
  • 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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  • K250907 — Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set (April 30, 2025)
  • K243649 — BD Vacutainer® Multiple Sample Luer Adapter (March 21, 2025)
  • K241586 — PIVO™ Pro Needle-free Blood Collection Device (February 27, 2025)
  • K242320 — BD Vacutainer® One Use Holder (November 1, 2024)
  • K233979 — VACUETTE® QUICKSHIELD Complete (Plus) (July 19, 2024)