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510(k) K853385

I.A.S.S., IV SET W/AIR VENT & I.A.P.S. W/O AIRVENT by Migada, Ltd. — Product Code FPA

K853385 is an FDA 510(k) premarket notification submitted by Migada, Ltd. for the device "I.A.S.S., IV SET W/AIR VENT & I.A.P.S. W/O AIRVENT". The FDA issued a decision of Substantially Equivalent on August 23, 1985. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Migada, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 23, 1985
Date Received
August 12, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, Intravascular
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

Other clearances by Migada, Ltd.

  • K954883 — FREE FLOW SAFETY DEVICE (April 23, 1996)
  • K943095 — IV TRANSFER SPIKE (September 30, 1994)
  • K933929 — LAB-SITE(R) SAFETY CANNULA (December 7, 1993)
  • K902881 — LAB-SITE SAFETY NEEDLE (September 26, 1990)
  • K870016 — ARTERIAL BLOOD GASSING MONITORING SYSTEM (ABG) (May 28, 1987)
  • K864453 — EMERGENCY & MILITARY INFUSION SYSTEM (January 20, 1987)
  • K863304 — PRESELECTED FLOW RATE I.V. SET (December 9, 1986)
  • K860952 — I.V. SET WITH AND WITHOUT AIR VENT (August 27, 1986)
  • K861275 — HIGH FLOW I.V. SET (June 2, 1986)
  • K860595 — TRANSFER SET (April 7, 1986)

Other clearances for product code FPA

  • K254123 — Ecomed Disposable Administration Sets (September 11, 2026)
  • K261530 — iiSure Infusion Set (June 3, 2026)
  • K252543 — AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, (May 4, 2026)
  • K251375 — PuraCath Firefly Needleless Connector IT (9005) (February 12, 2026)
  • K251257 — nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Fre (December 4, 2025)
  • K250325 — BD Alaris Pump Infusion Set (October 30, 2025)
  • K251814 — EZ™ IV Administration Set (August 29, 2025)
  • K251854 — SteadiSet infusion set (August 6, 2025)
  • K243841 — Sparta Infusion Set for Insulin (August 1, 2025)
  • K243392 — Infusomat® Space Volumetric Infusion Pump Administration Sets (July 24, 2025)

FDA data resources