Cleared Special

K233648 - Millipede 088 Access Catheter
(FDA 510(k) Clearance)

K233648 · Perfuze, Ltd. · Neurology

Dec 2023

Decision

30d

Days

Class 2

Risk

K233648 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 December 14, 2023, 30 days after receiving the submission on November 14, 2023. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number	K233648 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 14, 2023
Decision Date	December 14, 2023
Days to Decision	30 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