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510(k) K864997

MEDTRAC VP VOLUMETRIC INFUSION PUMP by American Edwards Laboratories — Product Code FRN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 1987
Date Received
December 22, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type

Other clearances by American Edwards Laboratories

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  • K872529 — THERMODILUTION CARDIAC OUTPUT COMPUTER, MOD. COM-2 (September 15, 1987)
  • K870444 — HOMEPRO II VOLUMETRIC INFUSION PUMP (April 17, 1987)
  • K864330 — SHEAR FORCE GAUGE (January 6, 1987)
  • K862724 — VEIN VALVE CUTTER (January 2, 1987)
  • K864155 — MODIFICATION OF CARPENTIER-EDWARDS BIOPROSTHESIS (November 20, 1986)
  • K863596 — CHIN-FOGARTY INFLATION DEVICE (November 20, 1986)
  • K863986 — XENON LIGHT SOURCE FOR ENDOSCOPIC PROCEDURES (October 31, 1986)
  • K862872 — FLEXIBLE VISUALIZATION CATHETER (October 24, 1986)

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