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510(k) K865096

NEW SECOND FRENCH SIZE MAHURKAR CATHETER by Quinton, Inc. — Product Code LFK

Clearance Details

Decision
SESD (Substantially Equivalent (with conditions))
Decision Date
February 18, 1987
Date Received
December 30, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Femoral
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 LFK

  • K971897 — CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATHETER 10 FR (CAVH) (October 21, 1997)
  • K914936 — CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATH SET (April 23, 1992)
  • K915215 — CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATH. KITS (March 27, 1992)
  • K891764 — FC-101 FEMORAL CATHETER GUIDE WIRE (April 7, 1989)
  • K891763 — FC-100 FEMORAL CATHETER (April 7, 1989)
  • K890717 — MODIFICATION HEMOFILTRATION CATHETER HF-100 (April 5, 1989)
  • K880775 — CONTINUOUS ARTERIAL/VENOUS HEMOFILTRATION TRAY (July 25, 1988)
  • K882466 — VAS-CATH PEDIATRIC HEMOFILTRATION CATHETER (July 13, 1988)
  • K863218 — CYTOSTATIC FILTRATION SET (February 12, 1987)
  • K862771 — MEDCOMP C.A.V.H. CATHETER (August 6, 1986)