Cleared Traditional

RIST Radial Access Catheter (K200417) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K200417 · Rist Neurovascular, Inc. · Neurology device
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May 2020
Decision
72d
Days
Class 2
Risk

K200417 is an FDA 510(k) clearance for the RIST Radial Access Catheter. Classified as Catheter, Percutaneous, Neurovasculature (product code QJP), Class II - Special Controls.

Submitted by Rist Neurovascular, Inc. (Miramar, US). The FDA issued a Cleared decision on May 2, 2020 after a review of 72 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Rist Neurovascular, Inc. devices

Submission Details

510(k) Number K200417 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 2020
Decision Date May 02, 2020
Days to Decision 72 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
76d faster than avg
Panel avg: 148d · This submission: 72d
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 90
Devices cleared under the same product code (QJP) and FDA review panel - the closest regulatory comparables to K200417.
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