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510(k) K060010

NAUTIFLUX by Sedat — Product Code DQO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 4, 2006
Date Received
January 3, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Diagnostic
Device Class
Class II
Regulation Number
870.1200
Review Panel
CV
Submission Type

Other clearances by Sedat

  • K082755 — SEDAT FLAMINGO (December 15, 2008)
  • K080472 — SEDAT MYSHELL LITE (April 23, 2008)
  • K042449 — DOLPHIN INFLATION DEVICE (April 18, 2005)
  • K040498 — MYSHELL (July 2, 2004)

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