Cleared Special

K250012 - Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set
(FDA 510(k) Clearance)

K250012 · Perfuze, Ltd. · Neurology

Feb 2025

Decision

55d

Days

Class 2

Risk

K250012 is an FDA 510(k) clearance for the 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 February 26, 2025, 55 days after receiving the submission on January 2, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number	K250012 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 02, 2025
Decision Date	February 26, 2025
Days to Decision	55 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.