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510(k) K991759

MAERSK MEDICAL CONTOUR INFUSION SET by Maersk Medical A/S — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 1999
Date Received
May 24, 1999
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 Maersk Medical A/S

  • K011071 — PARADIGM QUICK-SET INFUSION SET (June 7, 2001)
  • K004028 — ARGLAES-AB ANTIMICROBIAL BARRIER POWDER DRESSING (March 27, 2001)
  • K002138 — PARADIGM SILHOUETTE, MODELS MMT-377, 378, 379, 380 (August 29, 2000)
  • K990111 — DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4520, 4535, 4570 (December 6, 1999)
  • K990110 — DISPOSABLE ECG MONITORING ELECTRODES, MODEL 4110, 4140 (December 6, 1999)
  • K990115 — DISPOSABLE ECG MONITORING ELECTRODES, MODELS, 4420, 4440 (December 6, 1999)
  • K990112 — DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4060, 4610 (December 6, 1999)
  • K990113 — DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4500,4530, 4533, 4539, 4540, AND 45 (December 6, 1999)
  • K990810 — ARGLAES-AB ANTIMICROBIAL BARRIER FILM DRESSING & ISLAND DRESSING (September 17, 1999)
  • K973364 — 4L DRAINAGE BAG, 4L BAG FOR PERITONEAL DIALYSIS, 4L URINARY DRAINAGE BAG (March 17, 1998)

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  • K243392 — Infusomat® Space Volumetric Infusion Pump Administration Sets (July 24, 2025)
  • K250616 — Clave™ Neutral-Displacement Needlefree Connectors (June 5, 2025)
  • K242692 — SteadiSet Infusion Set (May 9, 2025)
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