Home / 510(k) Clearances / K160235

510(k) K160235

ViaValve Safety I.V. Catheter by Smiths Medical Asd, Inc. — Product Code FOZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 2016
Date Received
February 1, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Device Class
Class II
Regulation Number
880.5200
Review Panel
HO
Submission Type

Other clearances by Smiths Medical Asd, Inc.

  • K232943 — Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space Syringe (May 31, 2024)
  • K210833 — Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Trach (November 26, 2021)
  • K211634 — Hypodermic Needle-Pro EDGE Safety Device (August 26, 2021)
  • K192375 — Intellifuse Administration and Intellifuse Blood Administration Sets (September 18, 2020)
  • K181699 — Level 1 Convective Warmer (July 26, 2018)
  • K172800 — Portex® Lancet Point Spinal Needles with NRFit™ connectors, Portex® Pencil Point (June 14, 2018)
  • K172823 — Portex NRFit Epidural Needles (June 12, 2018)
  • K172410 — Portex NRFit Epidural Needles, Portex NRFit Spinal Needles, Portex NRFit Loss of (June 1, 2018)
  • K172592 — CADD Yellow High Volume Administration Set with NRFit connector (May 17, 2018)
  • K173912 — BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Perc (May 8, 2018)

Other clearances for product code FOZ

  • K252398 — SURFLO Hybria Closed System Safety IV Catheter (December 17, 2025)
  • K252677 — Polyshield Safety IV Catheters (November 5, 2025)
  • K251422 — BD Saf-T-Intima™ Subcutaneous Catheter System (October 8, 2025)
  • K243403 — BD Nexiva™ Closed IV Catheter System (July 25, 2025)
  • K251155 — BD Cathena™ Safety IV Catheter (July 11, 2025)
  • K251654 — BD Insyte™ Autoguard™ Shielded IV Catheter, BD Insyte™ Autoguard™ BC Shielded IV (June 27, 2025)
  • K250682 — BD Nexiva™ Diffusics™ Closed IV Catheter System and BD Nexiva™ Diffusics™ Closed (June 3, 2025)
  • K243105 — Ruby Intravascular Catheter (May 16, 2025)
  • K250292 — OSPREY Midline Closed IV Catheter System (OspreyEDC-F20) (May 2, 2025)
  • K244059 — HydroMID 5F Dual Lumen Midline Catheter - Basic Kit (70006102); HydroMID 5F Dual (March 27, 2025)