Cleared Traditional

K133177 - MODIFIED HD GUIDE CATHETER

K133177 is the FDA 510(k) clearance for MODIFIED HD GUIDE CATHETER by Concentric Medical, Inc.. It is a Class 2 Cardiovascular device (product code DQY) cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K133177 · Concentric Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2014
Decision
131d
Days
Class 2
Risk

K133177 is an FDA 510(k) clearance for the MODIFIED HD GUIDE CATHETER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Concentric Medical, Inc. (Mountain View, US). The FDA issued a Cleared decision on February 25, 2014 after a review of 131 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - 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 Concentric Medical, Inc. devices

Submission Details

510(k) Number K133177 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 2013
Decision Date February 25, 2014
Days to Decision 131 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
6d slower than avg
Panel avg: 125d · This submission: 131d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DQY Catheter, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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
NCT01088672 Completed Interventional Industry-sponsored

Thrombectomy REvascularization of Large Vessel Occlusions in Acute Ischemic Stroke (TREVO)

60
Patients (actual)
7
Sites
Treatment
Purpose
Open label
Masking
Condition studied Ischemic Stroke
Study design Single group
Eligibility All sexes · 18 Years+
Principal investigator Nils Wahlgren, MD
Sponsor Stryker Neurovascular (industry)
Started 2010-02-01 → Primary completion 2011-08-01 → Completed 2011-11-01
Primary outcome
Revascularization Status
Secondary outcome
Clinical Outcomes at 90 Days
View full study on ClinicalTrials.gov

Regulatory Peers - DQY Catheter, Percutaneous

All 573
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K133177.
ENVOY GUIDING CATHETER
K140307 · Codman & Shurtleff, Inc. · Apr 2014
ACUITY PRO LEAD DELIVERY SYSTEM
K132914 · Boston Scientific · Apr 2014
TOTAL ACROSS
K133539 · Medtronic Vascular · Mar 2014
LEADLINER CS LEAD DELIVERY SYSTEM
K133501 · Vascular Solutions, Inc. · Feb 2014
ADVANCE CS CORONARY SINUS INFUSION CATHETER
K131204 · Cook, Inc. · Jan 2014
SOFIA DISTAL ACCESS CATHETER
K131482 · MicroVention, Inc. · Nov 2013