Cleared Traditional

Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set

K232524 · Perfuze, Ltd. · Neurology

Oct 2023

Decision

61d

Days

Class 2

Risk

About This 510(k) Submission

K232524 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 October 18, 2023, 61 days after receiving the submission on August 18, 2023. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number	K232524 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 18, 2023
Decision Date	October 18, 2023
Days to Decision	61 days
Submission Type	Traditional
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.