Cleared Traditional

K240711 - Zipline Access Catheter

K240711 is the FDA 510(k) clearance for Zipline Access Catheter by Perfuze, Ltd.. It is a Class 2 Neurology device (product code QJP) cleared through the Traditional 510(k) pathway after a 216-day FDA review.

K240711 · Perfuze, Ltd. · Neurology device
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Oct 2024
Decision
216d
Days
Class 2
Risk

K240711 is an FDA 510(k) clearance for the Zipline Access Catheter. Classified as Catheter, Percutaneous, Neurovasculature (product code QJP), Class II - Special Controls.

Submitted by Perfuze, Ltd. (Galway, IE). The FDA issued a Cleared decision on October 17, 2024 after a review of 216 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 870.1250 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Perfuze, Ltd. devices

Submission Details

510(k) Number K240711 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
68d slower than avg
Panel avg: 148d · This submission: 216d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QJP Catheter, Percutaneous, Neurovasculature
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
Definition To Provide Vascular Access To The Neurovasculature For Interventional Or Diagnostic Procedures
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - QJP Catheter, Percutaneous, Neurovasculature

All 91
Devices cleared under the same product code (QJP) and FDA review panel - the closest regulatory comparables to K240711.
87 NeuGlide Catheter
K240971 · Piraeus Medical · Dec 2024
Socrates 38 Catheter
K242301 · Scientia Vascular, Inc. · Dec 2024
Neurovascular Access System Family
K240746 · Q'Apel Medical, Inc. · Nov 2024
CEREGLIDE 42 Intermediate Catheter
K241244 · Cerenovus, Inc. · Oct 2024
8F Modified Sheath System
K240529 · Route 92 Medical, Inc. · Oct 2024
Next Generation Access Catheter
K234074 · Balt USA, LLC · Jul 2024