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510(k) K112290

SUPERCATH Z3V by Togo Medikit Co., Ltd. — Product Code FOZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 2012
Date Received
August 9, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Device Class
Class II
Regulation Number
880.5200
Review Panel
HO
Submission Type

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  • K093546 — SUPERCATH 5 MODEL SP120-XX-XX, SP125-XX-XX (December 17, 2009)
  • K081953 — SUPERCATH 5 (March 12, 2009)

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