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510(k) K120961

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

K120961 is an FDA 510(k) premarket notification submitted by Concentric Medical, Inc. for the device "TREVO RETRIEVER". The FDA issued a decision of Substantially Equivalent on August 3, 2012. The device falls under product code NRY (Catheter, Thrombus Retriever), a Class II device regulated under 21 CFR 870.1250. Concentric Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 2012
Date Received
March 30, 2012
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)
  • K132641 — MODIFIED TREVO PROVUE RETRIEVER (January 13, 2014)
  • K131437 — MODIFIED CONCENTRIC MICROCATHETER (October 11, 2013)
  • K131492 — MODIFIED FLOWGATE BALLOON GUIDE CATHETER (October 3, 2013)

Other clearances for product code NRY

  • K261089 — Radical 064 Reperfusion Catheter; Radical 076 Reperfusion Catheter; Radical Aspi (September 14, 2026)
  • K260617 — Tigertriever 13 Ultra Revascularization Device (August 28, 2026)
  • K262398 — CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing set (August 13, 2026)
  • K262391 — APRO 35 Swift Catheter and Alembic Aspiration Tubing (August 12, 2026)
  • K262399 — Millipede System (August 12, 2026)
  • K260002 — Socrates Aspiration System (Socrates 70 Aspiration Catheter) (July 16, 2026)
  • K250690 — Penumbra System (Thunderbolt Aspiration Tubing) (June 10, 2026)
  • K252707 — Zenith Aspiration Catheter; Disposable Aspiration Tubing Set (May 20, 2026)
  • K254276 — Lynx Aspiration Catheter System (May 7, 2026)
  • K253590 — Millipede System (March 16, 2026)

FDA data resources