Cleared Traditional

Penumbra System (Reperfusion Catheter RED 62)

K203440 · Penumbra, Inc. · Neurology

May 2021

Decision

178d

Days

Class 2

Risk

About This 510(k) Submission

K203440 is an FDA 510(k) clearance for the Penumbra System (Reperfusion Catheter RED 62), a Catheter, Thrombus Retriever (Class II — Special Controls, product code NRY), submitted by Penumbra, Inc. (Alameda, US). The FDA issued a Cleared decision on May 20, 2021, 178 days after receiving the submission on November 23, 2020. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number	K203440 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 23, 2020
Decision Date	May 20, 2021
Days to Decision	178 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	NRY — Catheter, Thrombus Retriever
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.1250
Definition	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.