Cleared Traditional

K123111 - V8 TRANSLUMINAL BAV CATHETER (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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 20
Devices cleared under the same product code (OZT) and FDA review panel - the closest regulatory comparables to K123111.
Valvuloplasty Balloon Catheter (ValvuloPro)
K260437 · Dongguan TT Medical, Inc. · Mar 2026
OutFlo Aortic Valve Dilatation Balloon Catheter
K241562 · Disa Medinotec · Mar 2025
ValvuloPro Valvuloplasty Balloon Catheter
K240967 · Dongguan TT Medical, Inc. · Jul 2024
ValvuloPro Valvuloplasty Balloon Catheter
K231814 · Dongguan TT Medical, Inc. · Oct 2023
INOUE BALLOON A
K220881 · Toray Industries, Inc. · Dec 2022