Trevo XP ProVue Retriever— 510(k) K190779

Clearance details

Applicant

Stryker

Product code

Code POL

Device class

Class 2

Regulation

21 CFR 882.5600

Advisory panel

Neurology

Date received

2019-03-27

Decision date

2019-06-25

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Fremont, CA, US

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• Z-0114-2021 — Trevo XP ProVue Retriever, REF (Size): 90182 (4MM x 20MM); 90185 (4MM x 30MM); 90186 (6MM x 25MM). Procedure Pack REF: 80052, 93067, 93068, M0032PK42010001, M0033PK42022001, M0033PK43022001, M0033PK62523001, M0032PK42010002, M0032PK43010002, M0032PK62510002, M0033PK42022002, M0033PK43022002, M0033PK62523002Class I·Terminated·Stryker Neurovascular·20200921

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K190779.