Cleared Traditional

K142083 - TRUE FLOW VALVULOPLASTY PERFUSION CATHETER

K142083 is an FDA 510(k) clearance for TRUE FLOW VALVULOPLASTY PERFUSION CATHETER, manufactured by C.R. Bard, Inc.. The device is a Class 2 Cardiovascular device with product code OZT cleared through the Traditional 510(k) pathway after a 260-day FDA review.

K142083 · C.R. Bard, Inc. · Cardiovascular device
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Apr 2015
Decision
260d
Days
Class 2
Risk

K142083 is an FDA 510(k) clearance for the TRUE FLOW VALVULOPLASTY PERFUSION CATHETER. Classified as Balloon Aortic Valvuloplasty (product code OZT), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Tempe, US). The FDA issued a Cleared decision on April 17, 2015 after a review of 260 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 C.R. Bard, Inc. devices

FDA 510(k) Submission Details - K142083

510(k) Number K142083 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 2014
Decision Date April 17, 2015
Days to Decision 260 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
135d slower than avg
Panel avg: 125d · This submission: 260d
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 K142083.
True Flow Valvuloplasty Perfusion Catheter
K172932 · C.R. Bard, Inc. · Dec 2017
True Flow Valvuloplasty Perfusion Catheter
K152613 · C.R. Bard, Inc. · Jan 2016
True Dilatation Balloon Valvuloplasty Catheter
K150667 · C.R. Bard, Inc. · Jun 2015
Ascendra Balloon Aortic Valvaloplasty Catheter
K142199 · Edwards Lifesciences · Oct 2014
TRUE BA V BALLOON VALVULOPLASTY CATHETER
K141985 · C.R. Bard, Inc. · Sep 2014
EDWARDS TRANSFEMORAL BALLOON CATHETER
K140241 · Edwards Lifesciences, LLC · Jul 2014