Home / 510(k) Clearances / K843639

510(k) K843639

ADD-A-VIAL SOLUTION TRANSFER DEVICE by American Mcgaw — Product Code LHI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 1985
Date Received
September 17, 1984
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 American Mcgaw

  • K853549 — MCGAW/DROP WATCH FLOW MONITOR (November 12, 1985)
  • K843954 — MIXING CONTAINER (November 28, 1984)
  • K841729 — ACCUPRO ENTERAL FEEDING PUMP (June 1, 1984)
  • K840388 — PAB IV CONTAINER (March 6, 1984)
  • K840212 — CONCENTRATED PLATELET ADMIN. SET (March 6, 1984)
  • K831716 — CAPD - CATHETER ADAPTER (June 24, 1983)
  • K822240 — ETHYLENE OXIDE STERILIZ. PARAMETRIC REL. (December 30, 1982)
  • K820133 — MCGAW FAT EMULSION SET (April 6, 1982)
  • K813092 — ACCUPRO I.V. ADMINISTRATION SET (December 31, 1981)
  • K810683 — CAPD CATHETER ADAPTER (May 8, 1981)

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)