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510(k) K863596

CHIN-FOGARTY INFLATION DEVICE by American Edwards Laboratories — Product Code DXT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 20, 1986
Date Received
September 15, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Injector And Syringe, Angiographic
Device Class
Class II
Regulation Number
870.1650
Review Panel
HO
Submission Type

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  • K864997 — MEDTRAC VP VOLUMETRIC INFUSION PUMP (February 27, 1987)
  • K864330 — SHEAR FORCE GAUGE (January 6, 1987)
  • K862724 — VEIN VALVE CUTTER (January 2, 1987)
  • K864155 — MODIFICATION OF CARPENTIER-EDWARDS BIOPROSTHESIS (November 20, 1986)
  • K863986 — XENON LIGHT SOURCE FOR ENDOSCOPIC PROCEDURES (October 31, 1986)
  • K862872 — FLEXIBLE VISUALIZATION CATHETER (October 24, 1986)

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