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510(k) K850339

SPECIAL PROCEDURES PACK by Marwood Medical, Inc. — Product Code FPA

K850339 is an FDA 510(k) premarket notification submitted by Marwood Medical, Inc. for the device "SPECIAL PROCEDURES PACK". The FDA issued a decision of Substantially Equivalent on March 12, 1985. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Marwood Medical, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 1985
Date Received
January 28, 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 Marwood Medical, Inc.

  • K850340 — EYE PROCEDURE PACK (May 22, 1985)
  • K850338 — EMERGENCY ROOM PACK (March 25, 1985)
  • K850341 — CARDIOVASCULAR SET UP (February 25, 1985)
  • K850337 — CARDIAC CATHETERIZATION PACK (February 25, 1985)
  • K840620 — TPN/CVP DRESSING CHANGE KIT (May 30, 1984)
  • K840619 — I.V. START KIT (March 27, 1984)

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