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510(k) K110319

EVERCROSS 0.035 OTW PTA DILATATION CATHETER by Ev3, Inc. — Product Code LIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 2011
Date Received
February 3, 2011
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Angioplasty, Peripheral, Transluminal
Device Class
Class II
Regulation Number
870.1250
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)
  • 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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