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510(k) K093750

ECHELON MICRO CATHETER, MARATHON MICRO CATHETER, NAUTICA MICRO CATHETER ULTRAFLOW HPC FLOW DIRECTED MICRO CATHETER, REBA by Ev3, Inc. — Product Code KRA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 9, 2009
Date Received
December 7, 2009
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Continuous Flush
Device Class
Class II
Regulation Number
870.1210
Review Panel
CV
Submission Type

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  • K103618 — TURBOHAWK PEROPHERAL PLAQUE EXCISION SYSTEM (January 5, 2011)
  • K103322 — EVERCROSS 0.035 OTW PTA DILATION CATHETER (December 6, 2010)

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