Cleared Traditional

Zipline Access Catheter

K240711 · Perfuze, Ltd. · Neurology

Oct 2024

Decision

216d

Days

Class 2

Risk

About This 510(k) Submission

K240711 is an FDA 510(k) clearance for the Zipline 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 October 17, 2024, 216 days after receiving the submission on March 15, 2024. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number	K240711 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 15, 2024
Decision Date	October 17, 2024
Days to Decision	216 days
Submission Type	Traditional
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