Cleared Traditional

K123111 - V8 TRANSLUMINAL BAV CATHETER

K123111 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 Traditional 510(k) pathway after a 120-day FDA review.

K123111 · Intervalve, Inc. · Cardiovascular device
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Jan 2013
Decision
120d
Days
Class 2
Risk

K123111 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 January 31, 2013 after a review of 120 days - within the typical 510(k) review window.

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 Intervalve, Inc. devices

FDA 510(k) Submission Details - K123111

510(k) Number K123111 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 2012
Decision Date January 31, 2013
Days to Decision 120 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
5d faster than avg
Panel avg: 125d · This submission: 120d
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 16
Devices cleared under the same product code (OZT) and FDA review panel - the closest regulatory comparables to K123111.
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