Cleared Traditional

Benchmark BMX96 Access System

K213390 · Penumbra, Inc. · Neurology

Aug 2022

Decision

307d

Days

Class 2

Risk

About This 510(k) Submission

K213390 is an FDA 510(k) clearance for the Benchmark BMX96 Access System, a Catheter, Percutaneous, Neurovasculature (Class II — Special Controls, product code QJP), submitted by Penumbra, Inc. (Alameda, US). The FDA issued a Cleared decision on August 18, 2022, 307 days after receiving the submission on October 15, 2021. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number	K213390 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 15, 2021
Decision Date	August 18, 2022
Days to Decision	307 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	QJP — Catheter, Percutaneous, Neurovasculature
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.1250
Definition	To Provide Vascular Access To The Neurovasculature For Interventional Or Diagnostic Procedures