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510(k) K820859

COAXIAL DUAL FLOW CATHETER by Terumo Medical Corp. — Product Code LBW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 1982
Date Received
March 29, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Dialysis, Single Needle (Co-Axial Flow)
Device Class
Class II
Regulation Number
876.5540
Review Panel
GU
Submission Type

Other clearances by Terumo Medical Corp.

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  • K111556 — GLIDECROSS SUPPORT CATHETER (July 29, 2011)
  • K110540 — TERUMO SUPPORT CATHETER (May 13, 2011)
  • K102008 — GLIDESHEATH (July 21, 2010)
  • K091329 — PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH (May 29, 2009)
  • K082997 — TERUMO HYBRIA CLOSED SYSTEM SAFETY I.V. CATHETER (April 15, 2009)
  • K090040 — RADIFOCUS GLIDECATH (OR RADIFOCUS GLIDECATH XP) (February 6, 2009)
  • K082847 — PINNACLE ROII INTRODUCER SHEATH (October 29, 2008)
  • K082519 — FINECROSS MG CORONARY MICRO-GUIDE CATHETER (September 26, 2008)
  • K082736 — RADIFOCUS OPTITORQUE ANGIOGRAPHIC CATHETER (September 24, 2008)

Other clearances for product code LBW

  • K904433 — DUAL LUMEN NEEDLES (November 23, 1990)
  • K864629 — MODIFIED DUAL LUMEN NEEDLE (December 16, 1986)
  • K860515 — DUAL LUMEN NEEDLE (PRODUCT CHANGE) (March 4, 1986)
  • K801968 — HEMOCATH I KIDNEY DIALYSIS CATHETER (September 26, 1980)