Cleared Traditional

K231814 - ValvuloPro Valvuloplasty Balloon Catheter

K231814 is an FDA 510(k) clearance for ValvuloPro Valvuloplasty Balloon Catheter, manufactured by Dongguan TT Medical, Inc.. The device is a Class 2 Cardiovascular device with product code OZT cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K231814 · Dongguan TT Medical, Inc. · Cardiovascular device
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Oct 2023
Decision
113d
Days
Class 2
Risk

K231814 is an FDA 510(k) clearance for the ValvuloPro Valvuloplasty Balloon Catheter. Classified as Balloon Aortic Valvuloplasty (product code OZT), Class II - Special Controls.

Submitted by Dongguan TT Medical, Inc. (Dongguan, CN). The FDA issued a Cleared decision on October 12, 2023 after a review of 113 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 Dongguan TT Medical, Inc. devices

FDA 510(k) Submission Details - K231814

510(k) Number K231814 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 2023
Decision Date October 12, 2023
Days to Decision 113 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 faster than avg
Panel avg: 125d · This submission: 113d
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 21
Devices cleared under the same product code (OZT) and FDA review panel - the closest regulatory comparables to K231814.
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
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