Cleared Traditional

K120273 - KITTYCAT CATHETER

K120273 is the FDA 510(k) clearance for KITTYCAT CATHETER by Avinger, Inc.. It is a Class 2 Cardiovascular device (product code PDU) cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K120273 · Avinger, Inc. · Cardiovascular device
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Mar 2012
Decision
60d
Days
Class 2
Risk

K120273 is an FDA 510(k) clearance for the KITTYCAT CATHETER, KITTYCAT 2 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 March 30, 2012 after a review of 60 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

Submission Details

510(k) Number K120273 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 2012
Decision Date March 30, 2012
Days to Decision 60 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 125d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 24
Devices cleared under the same product code (PDU) and FDA review panel - the closest regulatory comparables to K120273.
XableCath Crossing Catheter
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K112308 · C.R. Bard, Inc. · Aug 2011
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MICRO GUIDE CATHETER XP
K082143 · Cordis Corp. · Aug 2008