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510(k) K770047

DNC 151 VINCA-FLO by Sorensen Research — Product Code FJT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 1977
Date Received
January 10, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Intracatheter, Dialysis
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

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  • K833095 — TRANSDUCER DOME SD105 (November 3, 1983)
  • K833096 — TRANSDUCER DOME DS106 (November 3, 1983)
  • K832957 — FLOW-DIRECTED HEPARIN COATED THERMODIL (September 29, 1983)
  • K831506 — DISP. TRANSDUCER W/MONITORING KIT TRANS (August 12, 1983)
  • K831939 — TALL FLOOR STAND TFS-01 (July 19, 1983)
  • K831505 — THORACIC GAUGE #TG-60 -VACUUM REGULATOR (July 12, 1983)
  • K820706 — WATERLESS SEAL & VACUUM REGULATOR (April 9, 1982)

Other clearances for product code FJT

  • K863297 — MODIFICATION'S TO TORAY'S B-2 SERIES (September 25, 1986)
  • K772146 — CATHETER, VEIN, FEMORAL, SF 10 (November 29, 1977)
  • K772148 — CATHETER, FEMORAL VEIN, SF 6 (November 29, 1977)
  • K760781 — TRIEX-1 HOLLOW FIBER DIALYZER (December 6, 1976)