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510(k) K140015

CARDIOSOLUTIONS DEXTERITY STEERABLE INTRODUCER by Cardiosolutions, Inc. — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 5, 2014
Date Received
January 2, 2014
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Introducer, Catheter
Device Class
Class II
Regulation Number
870.1340
Review Panel
CV
Submission Type

Other clearances by Cardiosolutions, Inc.

  • K131332 — CARDIOSOLUTIONS PERCU-PRO STEERABLE INTRODUCER (July 19, 2013)
  • K120086 — CARIOSOLUTIONS PERCU-PRO STEERABLE INTRODCER 65CM CARIOSOLUTIONS PERCU-PRO STEER (April 24, 2012)
  • K094048 — PERCUPRO MESSENGER BALLOON CATHETER (July 14, 2011)
  • K094062 — PERCU-PRO GUIDEWIRE (September 27, 2010)

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