Cleared Special

Millipede 088 Access Catheter

K231802 · Perfuze, Ltd. · Neurology

Sep 2023

Decision

91d

Days

Class 2

Risk

About This 510(k) Submission

K231802 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. (Dangan, IE). The FDA issued a Cleared decision on September 19, 2023, 91 days after receiving the submission on June 20, 2023. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number	K231802 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 20, 2023
Decision Date	September 19, 2023
Days to Decision	91 days
Submission Type	Special
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