Cleared Traditional

K142199 - Ascendra Balloon Aortic Valvaloplasty C...

K142199 is an FDA 510(k) clearance for Ascendra Balloon Aortic Valvaloplasty C..., manufactured by Edwards Lifesciences. The device is a Class 2 Cardiovascular device with product code OZT cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K142199 · Edwards Lifesciences · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2014
Decision
79d
Days
Class 2
Risk

K142199 is an FDA 510(k) clearance for the Ascendra Balloon Aortic Valvaloplasty Catheter. Classified as Balloon Aortic Valvuloplasty (product code OZT), Class II - Special Controls.

Submitted by Edwards Lifesciences (Irvine, US). The FDA issued a Cleared decision on October 29, 2014 after a review of 79 days - a notably fast clearance 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: 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 Edwards Lifesciences devices

FDA 510(k) Submission Details - K142199

510(k) Number K142199 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 2014
Decision Date October 29, 2014
Days to Decision 79 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
46d faster than avg
Panel avg: 125d · This submission: 79d
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 15
Devices cleared under the same product code (OZT) and FDA review panel - the closest regulatory comparables to K142199.
True Flow Valvuloplasty Perfusion Catheter
K152613 · C.R. Bard, Inc. · Jan 2016
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
EDWARDS TRANSFEMORAL BALLOON CATHETER
K140241 · Edwards Lifesciences, LLC · Jul 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