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FDA 510(k)

Valvuloplasty Balloon Catheter (ValvuloPro)

K-Number: K260437 · 2026-03-20

ApplicantDongguan TT Medical, Inc.
Decision Date2026-03-20
Product CodeOZT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Valvuloplasty Balloon Catheter (ValvuloPro) is a medical device manufactured by Dongguan TT Medical, Inc.. It received FDA 510(k) clearance on 2026-03-20 under approval number K260437. The device is classified under product code OZT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Valvuloplasty Balloon Catheter (ValvuloPro)?

Valvuloplasty Balloon Catheter (ValvuloPro) is a medical device that received FDA 510(k) clearance on 2026-03-20. It is manufactured by Dongguan TT Medical, Inc.. The 510(k) number is K260437.

When was Valvuloplasty Balloon Catheter (ValvuloPro) approved by the FDA?

Valvuloplasty Balloon Catheter (ValvuloPro) received FDA 510(k) clearance on 2026-03-20, under approval number K260437.

What company makes Valvuloplasty Balloon Catheter (ValvuloPro)?

Valvuloplasty Balloon Catheter (ValvuloPro) is manufactured by Dongguan TT Medical, Inc..

What is the FDA product code for Valvuloplasty Balloon Catheter (ValvuloPro)?

The FDA product code for Valvuloplasty Balloon Catheter (ValvuloPro) is OZT.

Related Clinical Trials

NCT04647253 A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR) ACTIVE_NOT_RECRUITING NCT06492174 A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR) - Long Lesion Cohort ACTIVE_NOT_RECRUITING NCT07214948 Open, Randomized Feasibility Trial on the Safety and Performance of the INGA Catheter for Labor Induction NOT_YET_RECRUITING NCT07414771 Safety and Usability of the Inga Catheter for Labor Induction (INGA-MDP) NOT_YET_RECRUITING NCT07587541 Low-VOLTage Area-Guided Catheter Ablation and SVC Isolation for Persistent Atrial Fibrillation Using a Balloon-in-Basket Pulsed Field Ablation Catheter NOT_YET_RECRUITING NCT07583706 A Single-center, Single-arm Study to Evaluate the Safety and Efficacy of Ultra-minimally Invasive Prostate Dilation in Treating Patients With Significant Obstructive Symptoms Caused by Benign Prostatic Hyperplasia RECRUITING

Related PubMed Literature

PMID: 41114311 From bench to bedside and back: translational cardiovascular interventions in veterinary medicine. Postepy w kardiologii interwencyjnej = Advances in interventional cardiology (2025)

Other Devices by Dongguan TT Medical, Inc.

K231814ValvuloPro Valvuloplasty Balloon Catheter K230374Coronary Dilatation Balloon Catheter (VesPenetrator®), Coronary Dilatation Balloon Catheter (VesTraveler®), Coronary Dilatation Balloon Catheter (VexPander®) K222663MultiStage Balloon Dilatation Catheter K222187Multistage Balloon Dilatation Catheter K240967ValvuloPro Valvuloplasty Balloon Catheter

Related Devices (Code: OZT)

K152613True Flow Valvuloplasty Perfusion CatheterC.R. Bard, Inc. K172932True Flow Valvuloplasty Perfusion CatheterC.R. Bard, Inc. K220881INOUE BALLOON AToray Industries, Inc. K231814ValvuloPro Valvuloplasty Balloon CatheterDongguan TT Medical, Inc. K240967ValvuloPro Valvuloplasty Balloon CatheterDongguan TT Medical, Inc. K241562OutFlo Aortic Valve Dilatation Balloon CatheterDisa Medinotec

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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