Cleared Special

K132728 - V8 TRANSLUMINAL BAV CATHETER

K132728 is an FDA 510(k) clearance for V8 TRANSLUMINAL BAV CATHETER, manufactured by Intervalve, Inc.. The device is a Class 2 Cardiovascular device with product code OZT cleared through the Special 510(k) pathway after a 80-day FDA review.

K132728 · Intervalve, Inc. · Cardiovascular device
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Nov 2013
Decision
80d
Days
Class 2
Risk

K132728 is an FDA 510(k) clearance for the V8 TRANSLUMINAL BAV CATHETER. Classified as Balloon Aortic Valvuloplasty (product code OZT), Class II - Special Controls.

Submitted by Intervalve, Inc. (Minneapolis, US). The FDA issued a Cleared decision on November 22, 2013 after a review of 80 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Intervalve, Inc. devices

FDA 510(k) Submission Details - K132728

510(k) Number K132728 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 2013
Decision Date November 22, 2013
Days to Decision 80 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 125d · This submission: 80d
Pathway characteristics
Modification to existing cleared device.

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 16
Devices cleared under the same product code (OZT) and FDA review panel - the closest regulatory comparables to K132728.
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
Z-MED Z-MED II
K122012 · NuMED, Inc. · Oct 2012
NUCLEUS-X PTV CATHETER
DEN080015 · NuMED, Inc. · Jun 2012