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510(k) K111723

TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM by Ev3, Inc. — Product Code MCW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 2011
Date Received
June 20, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Peripheral, Atherectomy
Device Class
Class II
Regulation Number
870.4875
Review Panel
CV
Submission Type

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  • K130911 — RAPIDCROSS PTA RAPID EXCHANGE BALLOON DILATATION CATHETER (May 24, 2013)
  • K123544 — RAPIDCROSS PTA RAPID EXCHANGE, BALLOON DILATATION CATHETER (February 12, 2013)
  • K111010 — SPIDERFX EMBOLIC PROTECTION DEVICE (October 27, 2011)
  • K111490 — MARKSMAN CATHETER, *REFERS TO DIFFERENT CATHETER WORKING LENGHTS, DISTAL SINGLE (September 16, 2011)
  • 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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