Cleared Traditional

CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set

K193380 · Codman & Shurtleff, Inc. · Neurology

Jul 2020

Decision

228d

Days

Class 2

Risk

About This 510(k) Submission

K193380 is an FDA 510(k) clearance for the CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set, a Catheter, Thrombus Retriever (Class II — Special Controls, product code NRY), submitted by Codman & Shurtleff, Inc. (Raynham, US). The FDA issued a Cleared decision on July 20, 2020, 228 days after receiving the submission on December 5, 2019. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number	K193380 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 05, 2019
Decision Date	July 20, 2020
Days to Decision	228 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.