Cleared Special

K233648 - Millipede 088 Access Catheter

K233648 is the FDA 510(k) clearance for Millipede 088 Access Catheter by Perfuze, Ltd.. It is a Class 2 Neurology device (product code QJP) cleared through the Special 510(k) pathway after a 30-day FDA review.

K233648 · Perfuze, Ltd. · Neurology device
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Dec 2023
Decision
30d
Days
Class 2
Risk

K233648 is an FDA 510(k) clearance for the Millipede 088 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 December 14, 2023 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 870.1250 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Perfuze, Ltd. devices

Submission Details

510(k) Number K233648 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 2023
Decision Date December 14, 2023
Days to Decision 30 days
Submission Type Special
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
118d faster than avg
Panel avg: 148d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 90
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