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510(k) K810894

FOGARTY FLEXIBLE CALIBRATOR by American Edwards Laboratories — Product Code DWP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 1981
Date Received
April 3, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dilator, Vessel, Surgical
Device Class
Class II
Regulation Number
870.4475
Review Panel
CV
Submission Type

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  • K862724 — VEIN VALVE CUTTER (January 2, 1987)
  • K863596 — CHIN-FOGARTY INFLATION DEVICE (November 20, 1986)
  • K864155 — MODIFICATION OF CARPENTIER-EDWARDS BIOPROSTHESIS (November 20, 1986)
  • K863986 — XENON LIGHT SOURCE FOR ENDOSCOPIC PROCEDURES (October 31, 1986)

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  • K960312 — RDI CARDIAC INSULATION PAD (April 19, 1996)
  • K912548 — LEMAITRE-BOOKWALTER VESSEL DEVICES (September 18, 1991)
  • K911475 — LAPAROSCOPIC VESSEL ARTICULATOR (July 2, 1991)
  • K910682 — ROBICSEK PROBE/RETRACTOR (May 8, 1991)