Cleared Traditional

K113838 - WILDCAT CATHETER

K113838 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 75-day FDA review.

K113838 · Avinger, Inc. · Cardiovascular device
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Mar 2012
Decision
75d
Days
Class 2
Risk

K113838 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. (Redwood City, US). The FDA issued a Cleared decision on March 12, 2012 after a review of 75 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Avinger, Inc. devices

FDA 510(k) Submission Details - K113838

510(k) Number K113838 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 2011
Decision Date March 12, 2012
Days to Decision 75 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
50d faster than avg
Panel avg: 125d · This submission: 75d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

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 K113838.
OCELOT SYSTEM
K122380 · Avinger, Inc. · Nov 2012
BIGBOSS CATHETERS MANTATAY CATHETER MANTARAY GUIDEWIRES
K120533 · Bridgepoint Medical · May 2012
KITTYCAT CATHETER, KITTYCAT 2 CATHETER
K120273 · Avinger, Inc. · Mar 2012
CROSSER RECANALIZATION SYSTEM
K112308 · C.R. Bard, Inc. · Aug 2011
WILDCAT CATHETER
K111338 · Avinger, Inc. · Aug 2011
POWERWIRE RADIOFREQUENCY GUIDEWIRE
K101615 · Baylis Medical Co., Inc. · Jul 2010