Cleared Traditional

K212167 - R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewire (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence.

K212167 · Vascular Solutions, LLC · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2022
Decision
212d
Days
Class 2
Risk

K212167 is an FDA 510(k) clearance for the R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrio.... Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Vascular Solutions, LLC (Minneapolis, US). The FDA issued a Cleared decision on February 9, 2022 after a review of 212 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1330 - the FDA cardiovascular device oversight 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 Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Vascular Solutions, LLC devices

Submission Details

510(k) Number K212167 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 2021
Decision Date February 09, 2022
Days to Decision 212 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
87d slower than avg
Panel avg: 125d · This submission: 212d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DQX Wire, Guide, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1330
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Cardiovascular devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT03988166 Completed Interventional Industry-sponsored

Chronic Total Occlusion Percutaneous Coronary Intervention Study

Chronic Total Occlusion Percutaneous Coronary Intervention CTO-PCI Study

150
Patients (actual)
13
Sites
Treatment
Purpose
Open label
Masking
Condition studied Chronic Total Occlusion; Ischemic Heart Disease; Chronic Total Occlusion of Coronary Artery
Study design Single group
Eligibility All sexes · 18 Years+
Principal investigator David E Kandzari, MD
Sponsor Vascular Solutions LLC (industry)
Started 2020-05-20 → Primary completion 2021-02-22
Primary outcome
Number of Participants With Procedure Success
Secondary outcome
Number of Participants With Successful Recanalization.
View full study on ClinicalTrials.gov

Regulatory Peers - DQX Wire, Guide, Catheter

All 762
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K212167.
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Solo Pace Fusion System (SOLOFUSE1)
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