Cleared Traditional

K133607 - V8 TRANSLUMINAL BAV CATHETER (FDA 510(k) Clearance)

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

K133607 · Intervalve, Inc. · Cardiovascular device
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Feb 2014
Decision
78d
Days
Class 2
Risk

K133607 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 February 11, 2014 after a review of 78 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 Intervalve, Inc. devices

Submission Details

510(k) Number K133607 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 2013
Decision Date February 11, 2014
Days to Decision 78 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
47d faster than avg
Panel avg: 125d · This submission: 78d
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 K133607.
Valvuloplasty Balloon Catheter (ValvuloPro)
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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