Home / 510(k) Clearances / K140730

510(k) K140730

VIAL2BAG DIRECT CONNECT by Medimop Medical Projects, Ltd. — Product Code LHI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 12, 2014
Date Received
March 24, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, I.V. Fluid Transfer
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

Other clearances by Medimop Medical Projects, Ltd.

  • K160503 — Vented Vial Adapter Transfer Device - 13mm (May 4, 2016)
  • K130179 — MP VIAL ADAPTER 13MM (August 8, 2013)
  • K132040 — VIAL CONNECTOR 13MM CLOSED COLLAR (July 31, 2013)
  • K122023 — MIXJECT WITH SPRAY HEAD (October 4, 2012)
  • K072511 — SWABABLE VIAL ADAPTER 13MM, SWABABLE VIAL ADAPTER 20MM (December 13, 2007)
  • K072759 — VIAL2BAG (December 13, 2007)
  • K062482 — VENTED VIAL ADAPTER TRANSFER DEVICE (November 3, 2006)
  • K031861 — MIX2VIAL TRANSFER DEVICE (July 29, 2003)
  • K001831 — NEEDLELESS TRANSFER DEVICE (July 11, 2000)
  • K001293 — MODIFICATION TO MIXJECT DISPENSING PIN/WITH DETACHABLE VIAL HOLDER/WITH DETACHAB (May 5, 2000)

Other clearances for product code LHI

  • K250345 — Medline Bag Decanter (October 24, 2025)
  • K251715 — FlowArt® Vial Access Device Vented (October 14, 2025)
  • K251676 — Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decan (September 16, 2025)
  • K243404 — HyHub™ and HyHub™ Duo Vial Access Devices (July 18, 2025)
  • K240761 — Arisure® Closed Male Luer with Spike Adapter (YM060) (March 21, 2025)
  • K243985 — Rio™ Drug Reconstitution Transfer Device (January 22, 2025)
  • K243486 — SmartSiteTM Vented Vial Access Device (December 6, 2024)
  • K241976 — nextaro® va, 15mm, 5µm (September 6, 2024)
  • K233287 — Vent Vial Adapter (July 26, 2024)
  • K232987 — FlowArt Valve for Vial Access (June 26, 2024)