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510(k) K813144

INTRAFLON, INTRAFLUX, INTRAVALVE by Exco, Inc. — Product Code DQR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 27, 1981
Date Received
November 5, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cannula, Catheter
Device Class
Class II
Regulation Number
870.1300
Review Panel
CV
Submission Type

Other clearances by Exco, Inc.

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  • K844203 — ENTERNAL FEEDING TUBE SILICONE-EF401, 402 & 403 (January 2, 1985)
  • K844174 — FLEXIBLE STAINLESS STEEL STYLET FOR ENTERNAL FEEDI (December 7, 1984)
  • K832628 — VYGON THORACIC DRAINAGE-VARIOUS #'S (January 30, 1984)
  • K831802 — LIFE VAC #2191 & 2192 (January 11, 1984)
  • K833079 — CENTRACATH #130,135 & 137-HEMOCATH # (December 29, 1983)
  • K830910 — MANOMETER SET C.V.P. #S 298/299 (April 5, 1983)
  • K822879 — ENTERAL NUTRITION 1 (November 16, 1982)
  • K822691 — VYGON EPIDURAL ANAESTHESIA TRAY (October 15, 1982)
  • K822836 — MICROFLEX-VENOFLUX (October 15, 1982)

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  • K030398 — CARDIACASSIST TRANSSEPTAL CANNULA SET, MODEL 5132-6221 (May 23, 2003)
  • K960098 — RMI INTERNAL MAMMARY ARTERY CANNULA (March 26, 1996)
  • K902674 — DATASCOPE ARTERIAL CANNULA W/ACCESS PORT (January 16, 1991)
  • K894784 — MODIFIED SHILEY FEMORAL VENOUS CANNULA (March 28, 1990)
  • K894243 — RMI ARTERIAL PERFUSION CANNULA (September 19, 1989)
  • K884628 — HARBORIN CENTRAL VENOUS CATHETER (May 15, 1989)
  • K884478 — DAIG COLLAPSIBLE STERILE SLEEVE (February 22, 1989)