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510(k) K802970

TERUMO HOLLOW FIBER OXYGENATOR by Terumo America, Inc. — Product Code DTZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 1981
Date Received
November 21, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Oxygenator, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4350
Review Panel
CV
Submission Type

Other clearances by Terumo America, Inc.

  • K811523 — PLASMA FLEX (September 9, 1981)
  • K802122 — CLIRANS TH13 HOLLOW FIBER DIALYZER (December 18, 1980)
  • K802441 — CLIRANS TH10 HOLLOW FIBER DIALYZER (December 18, 1980)
  • K801193 — CLIRANS TE15 HOLLOW FIBER DIALYZER (August 12, 1980)
  • K801194 — CLIRANS TE07 HOLLOW FIBER DIALYZER (August 12, 1980)
  • K801192 — CLIRANS TE10 HOLLOW FIBER DIALYZER (August 12, 1980)
  • K791411 — COAXIAL DUAL FLOW CATHETER (November 13, 1979)
  • K791173 — SURFLO INJECTION PLUG (July 30, 1979)
  • K790105 — TERUMO IMUGARD (May 24, 1979)
  • K772362 — AVF SET FOR SINGLE NEEDLE HEMODIALYSIS (March 17, 1978)

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