Cleared Traditional

K201682 - RIST Radial Access Catheter

K201682 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 98-day FDA review.

K201682 · Rist Neurovascular, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2020
Decision
98d
Days
Class 2
Risk

K201682 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 September 28, 2020 after a review of 98 days - within the typical 510(k) review window.

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 Rist Neurovascular, Inc. devices

Submission Details

510(k) Number K201682 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 2020
Decision Date September 28, 2020
Days to Decision 98 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
50d faster than avg
Panel avg: 148d · This submission: 98d
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 K201682.
TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T Large Distal Platform
K203764 · Imperative Care, Inc. · Mar 2021
BOSS 8F Balloon Guide Catheter
K203840 · Marblehead Medical, LLC · Jan 2021
Route 92 Medical 070 Access System
K203043 · Route 92 Medical, Inc. · Nov 2020
Route 92 Medical 088 Access System
K201518 · Route 92 Medical · Aug 2020
Anchor Dual Lumen Guidewire Catheter
K201076 · Aqure Medical, Inc. · Aug 2020
RIST Radial Access Catheter
K200417 · Rist Neurovascular, Inc. · May 2020