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510(k) K132641

MODIFIED TREVO PROVUE RETRIEVER by Concentric Medical, Inc. — Product Code NRY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 2014
Date Received
August 26, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Thrombus Retriever
Device Class
Class II
Regulation Number
870.1250
Review Panel
NE
Submission Type

The device is intended to restore blood flow by removing thrombus/clots in patients experiencing ischemic stroke. The prior clearances in this category have been limited to simply identifying catheter placed in the peripheral, coronary, and neurovasculature. It is felt that this is a unique claim and should not be combined with previously cleared catheters under a general procode.

Other clearances by Concentric Medical, Inc.

  • K173352 — Trevo Pro Vue Retriever and Trevo XP Pro Vue Retriever (Trevo Retriever) (February 15, 2018)
  • 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)
  • K131437 — MODIFIED CONCENTRIC MICROCATHETER (October 11, 2013)
  • K131492 — MODIFIED FLOWGATE BALLOON GUIDE CATHETER (October 3, 2013)
  • K122581 — MODIFIED BALLOON GUIDE CATHETER MODEL 90253, 90254 (November 21, 2012)

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  • K252046 — Zoom System (Zoom 4S Catheter) (October 30, 2025)
  • K251603 — Tigertriever 17 Ultra Revascularization Device (October 6, 2025)
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  • K251828 — CEREGLIDE 71 Catheter System; Cerenovus Aspiration Tubing Set (August 22, 2025)
  • K243948 — Raptor Aspiration Catheter; Balt Aspiration Tubing Set (June 3, 2025)
  • K243047 — Zoom 7X Catheter; Zoom Aspiration Tubing; Zoom POD Aspiration Tubing (May 28, 2025)