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510(k) K801193

CLIRANS TE15 HOLLOW FIBER DIALYZER by Terumo America, Inc. — Product Code KDJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 1980
Date Received
May 19, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, For Peritoneal Dialysis, Disposable
Device Class
Class II
Regulation Number
876.5630
Review Panel
GU
Submission Type

Other clearances by Terumo America, Inc.

  • K811523 — PLASMA FLEX (September 9, 1981)
  • K802970 — TERUMO HOLLOW FIBER OXYGENATOR (January 22, 1981)
  • K802122 — CLIRANS TH13 HOLLOW FIBER DIALYZER (December 18, 1980)
  • K802441 — CLIRANS TH10 HOLLOW FIBER DIALYZER (December 18, 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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  • K151620 — Firefly Peritoneal Dialysis Connector Disinfection System (January 20, 2016)
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