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510(k) K832957

FLOW-DIRECTED HEPARIN COATED THERMODIL by Sorensen Research — Product Code DYG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 1983
Date Received
August 31, 1983
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 Sorensen Research

  • K833674 — ACCURATE MEASUREMENT DEVICE KG-AMD (January 25, 1984)
  • K833673 — ACCURATE MEASUREMENT DEVICE EZ-AMD (December 29, 1983)
  • K833096 — TRANSDUCER DOME DS106 (November 3, 1983)
  • K833094 — TRANSDUCER DOME SD104 (November 3, 1983)
  • K833095 — TRANSDUCER DOME SD105 (November 3, 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)
  • K813464 — DISPOSABLE TRANSDUCER (January 7, 1982)

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