Cleared Special

Millipede 088 Access Catheter; Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set

K242504 · Perfuze, Ltd. · Neurology

Sep 2024

Decision

29d

Days

Class 2

Risk

About This 510(k) Submission

K242504 is an FDA 510(k) clearance for the Millipede 088 Access Catheter; Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set, a Catheter, Thrombus Retriever (Class II — Special Controls, product code NRY), submitted by Perfuze, Ltd. (Galway, IE). The FDA issued a Cleared decision on September 20, 2024, 29 days after receiving the submission on August 22, 2024. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number	K242504 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 22, 2024
Decision Date	September 20, 2024
Days to Decision	29 days
Submission Type	Special
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.