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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
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 Consultant

Libramedical, Inc.
Ming Cheng Chew

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - OZT Balloon Aortic Valvuloplasty

All 21
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
V8 Transluminal BAV Catheter
K150343 · Intervalve, Inc. · Apr 2015
K152150 · V8 Balloon Aortic Valvuloplasty Catheter
Download PDF FDA Summary Intervalve, Inc.