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510(k) K862724

VEIN VALVE CUTTER by American Edwards Laboratories — Product Code DQY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 2, 1987
Date Received
July 17, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Percutaneous
Device Class
Class II
Regulation Number
870.1250
Review Panel
CV
Submission Type

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  • 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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