Cleared Traditional

K201076 - Anchor Dual Lumen Guidewire Catheter

K201076 is the FDA 510(k) clearance for Anchor Dual Lumen Guidewire Catheter by Aqure Medical, Inc.. It is a Class 2 Neurology device (product code QJP) cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K201076 · Aqure Medical, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2020
Decision
106d
Days
Class 2
Risk

K201076 is an FDA 510(k) clearance for the Anchor Dual Lumen Guidewire Catheter. Classified as Catheter, Percutaneous, Neurovasculature (product code QJP), Class II - Special Controls.

Submitted by Aqure Medical, Inc. (Rogers, US). The FDA issued a Cleared decision on August 6, 2020 after a review of 106 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 Aqure Medical, Inc. devices

Submission Details

510(k) Number K201076 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 2020
Decision Date August 06, 2020
Days to Decision 106 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 148d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Regulatory Technology Services, LLC
Prithul Bom

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K201076.
Route 92 Medical 070 Access System
K203043 · Route 92 Medical, Inc. · Nov 2020
RIST Radial Access Catheter
K201682 · Rist Neurovascular, Inc. · Sep 2020
Route 92 Medical 088 Access System
K201518 · Route 92 Medical · Aug 2020
RIST Radial Access Catheter
K200417 · Rist Neurovascular, Inc. · May 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