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510(k) K131437

MODIFIED CONCENTRIC MICROCATHETER by Concentric Medical, Inc. — Product Code DQO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 11, 2013
Date Received
May 20, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Diagnostic
Device Class
Class II
Regulation Number
870.1200
Review Panel
CV
Submission Type

Other clearances by Concentric Medical, Inc.

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  • 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)
  • K131492 — MODIFIED FLOWGATE BALLOON GUIDE CATHETER (October 3, 2013)
  • K122581 — MODIFIED BALLOON GUIDE CATHETER MODEL 90253, 90254 (November 21, 2012)

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