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510(k) K120086

CARIOSOLUTIONS PERCU-PRO STEERABLE INTRODCER 65CM CARIOSOLUTIONS PERCU-PRO STEERABLE INTRODUCER 80CM by Cardiosolutions — Product Code DRA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 2012
Date Received
January 11, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Steerable
Device Class
Class II
Regulation Number
870.1280
Review Panel
CV
Submission Type

Other clearances by Cardiosolutions

  • K140015 — CARDIOSOLUTIONS DEXTERITY STEERABLE INTRODUCER (February 5, 2014)
  • K131332 — CARDIOSOLUTIONS PERCU-PRO STEERABLE INTRODUCER (July 19, 2013)
  • K094048 — PERCUPRO MESSENGER BALLOON CATHETER (July 14, 2011)
  • K094062 — PERCU-PRO GUIDEWIRE (September 27, 2010)

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