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510(k) K103618

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 5, 2011
Date Received
December 10, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

Other clearances by Ev3, Inc.

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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)
  • K111723 — TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM (October 27, 2011)
  • 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)
  • 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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