Cleared Traditional

K200417 - RIST Radial Access Catheter

K200417 is the FDA 510(k) clearance for RIST Radial Access Catheter by Rist Neurovascular, Inc.. It is a Class 2 Neurology device (product code QJP) cleared through the Traditional 510(k) pathway after a 72-day FDA review.

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.
RIST Radial Access Catheter
K201682 · Rist Neurovascular, Inc. · Sep 2020
Route 92 Medical 088 Access System
K201518 · Route 92 Medical · Aug 2020
Anchor Dual Lumen Guidewire Catheter
K201076 · Aqure Medical, Inc. · Aug 2020
BOSS Balloon Guide Catheter
K200910 · Marblehead Medical · May 2020
Route 92 Medical 088 Access System, 110 cm
K200121 · Route 92 Medical, Inc. · Apr 2020
CEREBASE DA Guide Sheath, 95cm, CEREBASE DA Guide Sheath, 90cm, CEREBASE DA Guide Sheath, 80cm, CEREBASE DA Guide Sheath, 70cm
K192804 · Medos International SARL · Feb 2020