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510(k) K802481

7FRENCH FLOW DIRECTED TRIPLE LUMEN CATH by Waters Assoc., Inc. — Product Code DYG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 1980
Date Received
October 7, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Flow Directed
Device Class
Class II
Regulation Number
870.1240
Review Panel
CV
Submission Type

Other clearances by Waters Assoc., Inc.

  • K811975 — MODEL 480 VARIABLE WAVELENGTH ULTRA VIOL (July 27, 1981)
  • K801852 — MRM-2 OXYGEN CONSUMPTION MONITOR (August 20, 1980)
  • K801431 — PAN-AM MYELOGRAM TRAY (August 12, 1980)
  • K791661 — SYSTEM CONTROLLER 720 SERIES (September 24, 1979)
  • K791026 — 4F STERILE BALLOON-LESS, CATHETER 913-28 (June 22, 1979)
  • K782175 — CARTRIDGE HOLDER, RCM 100 (February 15, 1979)
  • K790145 — SOLVENT DELIVERY SYSTEM (February 15, 1979)
  • K781805 — CARDIAC COMPUTERS, CO-10 & CO-10R (January 29, 1979)
  • K781915 — DATA MODULE (January 10, 1979)
  • K781692 — CALIBRATOR, DYNAMIC (November 29, 1978)

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