Cleared Traditional

K140241 - EDWARDS TRANSFEMORAL BALLOON CATHETER

K140241 is an FDA 510(k) clearance for EDWARDS TRANSFEMORAL BALLOON CATHETER, manufactured by Edwards Lifesciences, LLC. The device is a Class 2 Cardiovascular device with product code OZT cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K140241 · Edwards Lifesciences, LLC · Cardiovascular device
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Jul 2014
Decision
154d
Days
Class 2
Risk

K140241 is an FDA 510(k) clearance for the EDWARDS TRANSFEMORAL BALLOON CATHETER. Classified as Balloon Aortic Valvuloplasty (product code OZT), Class II - Special Controls.

Submitted by Edwards Lifesciences, LLC (Irvine, US). The FDA issued a Cleared decision on July 3, 2014 after a review of 154 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1255 - 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 Edwards Lifesciences, LLC devices

FDA 510(k) Submission Details - K140241

510(k) Number K140241 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 2014
Decision Date July 03, 2014
Days to Decision 154 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
29d slower than avg
Panel avg: 125d · This submission: 154d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OZT Device Classification - Class 2, Special Controls

Product Code OZT Balloon Aortic Valvuloplasty
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1255
Definition A Balloon Aortic Valvuloplasty Catheter Is Indicated For Balloon Valvuloplasty Of The Aortic Valve.
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 - OZT Balloon Aortic Valvuloplasty

All 14
Devices cleared under the same product code (OZT) and FDA review panel - the closest regulatory comparables to K140241.
True Dilatation Balloon Valvuloplasty Catheter
K150667 · C.R. Bard, Inc. · Jun 2015
TRUE FLOW VALVULOPLASTY PERFUSION CATHETER
K142083 · C.R. Bard, Inc. · Apr 2015
TRUE BA V BALLOON VALVULOPLASTY CATHETER
K141985 · C.R. Bard, Inc. · Sep 2014
TRUE DILATATION BALLOON VALVULOPLASTY CATHETER, 20MM X 4.5 CM, 22MM X 4.5CM, 24 MM X 4.5CM, 26MM X 4.5CM
K133569 · Bard Peripheral Vascular, Inc. · Dec 2013
Z-MED Z-MED II
K122012 · NuMED, Inc. · Oct 2012
NUCLEUS-X PTV CATHETER
DEN080015 · NuMED, Inc. · Jun 2012