Cleared Traditional

Millipede 088 Access Catheter

K214048 · Perfuze, Ltd. · Neurology

Sep 2022

Decision

267d

Days

Class 2

Risk

About This 510(k) Submission

K214048 is an FDA 510(k) clearance for the Millipede 088 Access Catheter, a Catheter, Percutaneous, Neurovasculature (Class II — Special Controls, product code QJP), submitted by Perfuze, Ltd. (Galway, IE). The FDA issued a Cleared decision on September 20, 2022, 267 days after receiving the submission on December 27, 2021. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number	K214048 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 27, 2021
Decision Date	September 20, 2022
Days to Decision	267 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