Cleared Traditional

K111338 - WILDCAT CATHETER

K111338 is an FDA 510(k) clearance for WILDCAT CATHETER, manufactured by Avinger, Inc.. The device is a Class 2 Cardiovascular device with product code PDU cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K111338 · Avinger, Inc. · Cardiovascular device
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Aug 2011
Decision
91d
Days
Class 2
Risk

K111338 is an FDA 510(k) clearance for the WILDCAT CATHETER. Classified as Catheter For Crossing Total Occlusions (product code PDU), Class II - Special Controls.

Submitted by Avinger, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on August 11, 2011 after a review of 91 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 Avinger, Inc. devices

FDA 510(k) Submission Details - K111338

510(k) Number K111338 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 2011
Decision Date August 11, 2011
Days to Decision 91 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
34d faster than avg
Panel avg: 125d · This submission: 91d
Pathway characteristics
Predicate-based equivalence.

PDU Device Classification - Class 2, Special Controls

Product Code PDU Catheter For Crossing Total Occlusions
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
Definition To Facilitate The Intraluminal Placement Of Conventional Guidewires Beyond Stenotic Lesions (including Subchronic And Chronic Total Occlusions) In The Peripheral Vasculature Prior To Further Percutaneous Intervention, Such As Angioplasty, Atherectomy Or Stent Placement.
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
NCT01174784 Completed Interventional Industry-sponsored

Chronic Total Occlusion Crossing With the Wildcat Catheter

A Non-randomized Study of the Avinger Wildcat Used to Cross Femoropopliteal CTOs

88
Patients (actual)
15
Sites
Treatment
Purpose
Open label
Masking
Condition studied Peripheral Arterial Disease
Study design Single group
Eligibility All sexes · 19 Years+
Principal investigator Tom Davis, MD
Sponsor Avinger, Inc. (industry)
Started 2010-08-01 → Primary completion 2011-04-01 → Completed 2011-06-01
Primary outcome
Major Adverse Events
View full study on ClinicalTrials.gov

Regulatory Peers - PDU Catheter For Crossing Total Occlusions

All 49
Devices cleared under the same product code (PDU) and FDA review panel - the closest regulatory comparables to K111338.
KITTYCAT CATHETER, KITTYCAT 2 CATHETER
K120273 · Avinger, Inc. · Mar 2012
WILDCAT CATHETER
K113838 · Avinger, Inc. · Mar 2012
CROSSER RECANALIZATION SYSTEM
K112308 · C.R. Bard, Inc. · Aug 2011
POWERWIRE RADIOFREQUENCY GUIDEWIRE
K101615 · Baylis Medical Co., Inc. · Jul 2010
PIONEER PLUS CATHETER, MODEL PLUS 120
K101777 · Medtronic Vascular · Jul 2010
MICRO GUIDE CATHETER XP
K082143 · Cordis Corp. · Aug 2008