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510(k) K860515

DUAL LUMEN NEEDLE (PRODUCT CHANGE) by Quinton, Inc. — Product Code LBW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 4, 1986
Date Received
February 11, 1986
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 Quinton, Inc.

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  • K021906 — QUINTON Q-CATH, MODEL 000460 (September 4, 2002)
  • K003576 — Q-TEL RMS (REHABILITATION MANAGEMENT SYSTEM), MODEL 000503 (January 25, 2001)
  • K001492 — QUINTON Q-STRESS, MODEL 000483 (August 9, 2000)
  • K992908 — Q-TEL TELEMETRY SYSTEM V. 6.0 (ST) (March 6, 2000)
  • K990866 — QUINTON MEDTRACK CR PLUS TREADMILL (April 29, 1999)
  • K971397 — VIEWCATH 3-D CATHETER PULLBACK (August 25, 1997)
  • K964784 — SYNERGY CARDIOLOGY INFORMATION SYSTEM (00431) (August 13, 1997)
  • K964978 — VITAL STATISTICS SYSTEM (O-CATH ACCESSORY) (May 21, 1997)
  • K955002 — MAHURKAR 8 FR DUAL LEMEN CATHETER (September 13, 1996)

Other clearances for product code LBW

  • K904433 — DUAL LUMEN NEEDLES (November 23, 1990)
  • K864629 — MODIFIED DUAL LUMEN NEEDLE (December 16, 1986)
  • K820859 — COAXIAL DUAL FLOW CATHETER (April 16, 1982)
  • K801968 — HEMOCATH I KIDNEY DIALYSIS CATHETER (September 26, 1980)