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510(k) K112404

CONCENTRIC BALLOON GUIDE CATHETER by Concentric Medical, Inc. — Product Code DQY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 2012
Date Received
August 22, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Catheter, Percutaneous
Device Class
Class II
Regulation Number
870.1250
Review Panel
CV
Submission Type

Other clearances by Concentric Medical, Inc.

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  • DEN150049 — Modified Trevo ProVue Retriever, Trevo XP ProVue Retriever 4x20mm, Trevo XP ProV (September 2, 2016)
  • K153729 — 8F FlowGate2 Balloon Guide Catheter (January 27, 2016)
  • K150616 — Trevo XP ProVue Retriever (4x30mm) (June 12, 2015)
  • K143077 — Trevo XP ProVue Retriever (6X25mm) (April 6, 2015)
  • K133177 — MODIFIED HD GUIDE CATHETER (February 25, 2014)
  • K133464 — MODIFIED TREVO PROVUE RETRIEVER (January 17, 2014)
  • K132641 — MODIFIED TREVO PROVUE RETRIEVER (January 13, 2014)
  • K131437 — MODIFIED CONCENTRIC MICROCATHETER (October 11, 2013)
  • K131492 — MODIFIED FLOWGATE BALLOON GUIDE CATHETER (October 3, 2013)

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