Cleared Traditional

K152150 - V8 Balloon Aortic Valvuloplasty Catheter

K152150 is an FDA 510(k) clearance for V8 Balloon Aortic Valvuloplasty 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 137-day FDA review.

K152150 · Intervalve, Inc. · Cardiovascular device
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Dec 2015
Decision
137d
Days
Class 2
Risk

K152150 is an FDA 510(k) clearance for the V8 Balloon Aortic Valvuloplasty Catheter. Classified as Balloon Aortic Valvuloplasty (product code OZT), Class II - Special Controls.

Submitted by Intervalve, Inc. (Plymouth, US). The FDA issued a Cleared decision on December 18, 2015 after a review of 137 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 - K152150

510(k) Number K152150 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 2015
Decision Date December 18, 2015
Days to Decision 137 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
12d slower than avg
Panel avg: 125d · This submission: 137d
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 K152150.
INOUE BALLOON A
K220881 · Toray Industries, Inc. · Dec 2022
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
TRUE FLOW VALVULOPLASTY PERFUSION CATHETER
K142083 · C.R. Bard, Inc. · Apr 2015
Ascendra Balloon Aortic Valvaloplasty Catheter
K142199 · Edwards Lifesciences · Oct 2014