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510(k) K840339

UMBILICAL VESSEL CATHETER by Catheter Technology Corp. — Product Code FOS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 1984
Date Received
January 25, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Umbilical Artery
Device Class
Class II
Regulation Number
880.5200
Review Panel
HO
Submission Type

Other clearances by Catheter Technology Corp.

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  • K871080 — PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (August 12, 1987)
  • K871998 — GROSHONG CV CATHETER REPAIR KIT (June 24, 1987)
  • K860256 — BRAWN AND GROSHONG CATHETERS (March 28, 1986)
  • K842577 — CATH-TECH POLYURETHANE UMBILICAL VESS (March 13, 1985)
  • K842147 — CATH-TECH CHOLANGIOGRAPHY CATHETER (October 2, 1984)
  • K831386 — GROSHONG CATHETER, LONG TERM TYPE (October 14, 1983)
  • K831365 — TESTCORP ANA (June 2, 1983)
  • K831361 — BETA-PREG (June 2, 1983)
  • K831366 — TESTCORP PREG (June 2, 1983)

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  • K981630 — VYGON DOUBLE LUMEN UMBILICAL CATHETER (October 1, 1998)
  • K963972 — NEO-CARE DUAL LUMEN UMBILICAL CATHETER (December 24, 1996)
  • K954300 — ARGYLE NEO-SERT HYDROPHILIC POLYURETHANE UMBILICAL VESSEL CATHETER INSERTION TRA (December 13, 1995)