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510(k) K111490

MARKSMAN CATHETER, *REFERS TO DIFFERENT CATHETER WORKING LENGHTS, DISTAL SINGLE COILED LENGTHS AND DISTAL SHAFT LENGTHS by Ev3, Inc. — Product Code KRA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 2011
Date Received
May 31, 2011
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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  • K110319 — EVERCROSS 0.035 OTW PTA DILATATION CATHETER (April 14, 2011)
  • K103618 — TURBOHAWK PEROPHERAL PLAQUE EXCISION SYSTEM (January 5, 2011)
  • K103322 — EVERCROSS 0.035 OTW PTA DILATION CATHETER (December 6, 2010)
  • K100063 — HYPERFORM OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER, HYP (February 2, 2010)

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