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510(k) K160592

SUPERCATH 6 by Togo Medikit Co., Ltd. — Product Code FOZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 2016
Date Received
March 1, 2016
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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