Cleared Traditional

Penumbra System (Reperfusion Catheter RED 72)

K242104 · Penumbra, Inc. · Neurology

Feb 2025

Decision

210d

Days

Class 2

Risk

About This 510(k) Submission

K242104 is an FDA 510(k) clearance for the Penumbra System (Reperfusion Catheter RED 72), a Catheter, Thrombus Retriever (Class II — Special Controls, product code NRY), submitted by Penumbra, Inc. (Alameda, US). The FDA issued a Cleared decision on February 13, 2025, 210 days after receiving the submission on July 18, 2024. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number	K242104 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 18, 2024
Decision Date	February 13, 2025
Days to Decision	210 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.