MODIFIED TREVO PROVUE RETRIEVER— 510(k) K132641

Clearance details

Applicant

Concentric Medical, Inc.

Product code

Code NRY

Device class

Class 2

Regulation

21 CFR 870.1250

Advisory panel

Cardiovascular

Date received

2013-08-26

Decision date

2014-01-13

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Mountain View, CA, US

• K260617 — Tigertriever 13 Ultra Revascularization Device2026-08-28
• K262398 — CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing set2026-08-13
• K262391 — APRO 35 Swift Catheter and Alembic Aspiration Tubing2026-08-12
• K262399 — Millipede System2026-08-12
• K260002 — Socrates Aspiration System (Socrates 70 Aspiration Catheter)2026-07-16

• K173352 — Trevo Pro Vue Retriever and Trevo XP Pro Vue Retriever (Trevo Retriever)2018-02-15
• DEN150049 — Modified Trevo ProVue Retriever, Trevo XP ProVue Retriever 4x20mm, Trevo XP ProVue Retriever 3x20mm, Trevo XP ProVue Retriever 6x25mm, Trevo XP ProVue Retriever 4x30mm2016-09-02
• K150616 — Trevo XP ProVue Retriever (4x30mm)2015-06-12
• K143077 — Trevo XP ProVue Retriever (6X25mm)2015-04-06
• K133177 — MODIFIED HD GUIDE CATHETER2014-02-25

Death

411

Injury

1,712

Malfunction

1,855

Total

3,978

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-0347-2018 — Trevo XP ProVue System kit containing 1) Trevo XP ProVue Retriever, 4x20mm and 2) Trevo Pro18 MicrocatheterClass II·Terminated·Stryker Neurovascular·20171128
• Z-0275-2018 — Stroke Fast Pack(TM), Trevo(TM) XP, TREVO(TM) XP PROVUE RETRIEVER, 6 mm, 25 mm; Excelsior(TM) XT-27(tm), MICROCATHETER,150 cm, 6 cm; AXS Catalyst(TM) 6, Distal Access Catheter, 0.060 in, 132 cm, UPN M0033PK62523002 Stroke intervention kitClass II·Terminated·Stryker Neurovascular·20171103
• Z-0276-2018 — Stroke Fast Pack(TM), Trevo(TM) XP, TREVO(TM) XP PROVUE RETRIEVER, 4 mm, 20 mm, ; Trevo(TM) Pro 18, TREVO PRO 18 MICROCATHETER, 0.021 in ID, 150 cm; AXS Catalyst(TM) 6, Distal Access Catheter, 0.060 in, 132 cm; UPN M0033PK42022002 Stroke intervention kitClass II·Terminated·Stryker Neurovascular·20171103
• Z-0277-2018 — Trevo(TM) XP ProVue Procedure Pack, TREVO(TM) XP PROVUE RETRIEVER, 6 mm, 25 mm, .Excelsior(TM) XT-27(TM) 1 TIP STRAIGHT, 150 cm, 6 cm, Microcatheter; UPN 93068 Stroke intervention kitClass II·Terminated·Stryker Neurovascular·20171103

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K132641.