Cleared Special

Rist 079 Radial Access Guide Catheter (K241388) - FDA 510(k) Clearance

Also marketed or referenced as:
Rist 071 Radial Access Guide Catheter Rist Radial Access Selective Catheter

Class II Neurology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K241388 · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2025
Decision
232d
Days
Class 2
Risk

K241388 is an FDA 510(k) clearance for the Rist 079 Radial Access Guide Catheter. Classified as Catheter, Percutaneous, Neurovasculature (product code QJP), Class II - Special Controls.

Submitted by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular (Irvine, US). The FDA issued a Cleared decision on January 2, 2025 after a review of 232 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Micro Therapeutics, Inc. d/b/a ev3 Neurovascular devices

Submission Details

510(k) Number K241388 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 2024
Decision Date January 02, 2025
Days to Decision 232 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
84d slower than avg
Panel avg: 148d · This submission: 232d
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
Devices cleared under the same product code (QJP) and FDA review panel - the closest regulatory comparables to K241388.
Zenith Distal Access Long Sheath
K253359 · Suzhou Zenith Vascular SciTech Limited · May 2026
SAYA 86 Radial Access Guide Catheter
K254178 · Asahi Intecc Co., Ltd. · May 2026
BosCATH Support Catheter
K254046 · Sonorous NV, Inc. · Apr 2026
Next Generation 088 Catheter
K254223 · Balt USA, LLC · Apr 2026
PATH BGC
K260938 · Crossroads Neurovascular, Inc. · Apr 2026
Radical 6F Access Catheter
K253975 · Maduro Medical, Inc. · Apr 2026