Cleared Traditional

Penumbra System (RED 68 Reperfusion Catheter)

K211411 · Penumbra, Inc. · Neurology

Jul 2021

Decision

56d

Days

Class 2

Risk

About This 510(k) Submission

K211411 is an FDA 510(k) clearance for the Penumbra System (RED 68 Reperfusion Catheter), a Catheter, Thrombus Retriever (Class II — Special Controls, product code NRY), submitted by Penumbra, Inc. (Alameda, US). The FDA issued a Cleared decision on July 1, 2021, 56 days after receiving the submission on May 6, 2021. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number	K211411 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 06, 2021
Decision Date	July 01, 2021
Days to Decision	56 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.