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FDA 510(k)

ValvuloPro Valvuloplasty Balloon Catheter

K-Number: K231814 · 2023-10-12

ApplicantDongguan TT Medical, Inc.
Decision Date2023-10-12
Product CodeOZT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ValvuloPro Valvuloplasty Balloon Catheter is a medical device manufactured by Dongguan TT Medical, Inc.. It received FDA 510(k) clearance on 2023-10-12 under approval number K231814. 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 ValvuloPro Valvuloplasty Balloon Catheter?

ValvuloPro Valvuloplasty Balloon Catheter is a medical device that received FDA 510(k) clearance on 2023-10-12. It is manufactured by Dongguan TT Medical, Inc.. The 510(k) number is K231814.

When was ValvuloPro Valvuloplasty Balloon Catheter approved by the FDA?

ValvuloPro Valvuloplasty Balloon Catheter received FDA 510(k) clearance on 2023-10-12, under approval number K231814.

What company makes ValvuloPro Valvuloplasty Balloon Catheter?

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

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

The FDA product code for ValvuloPro Valvuloplasty Balloon Catheter 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.

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 K260437Valvuloplasty Balloon Catheter (ValvuloPro)

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. K240967ValvuloPro Valvuloplasty Balloon CatheterDongguan TT Medical, Inc. K241562OutFlo Aortic Valve Dilatation Balloon CatheterDisa Medinotec K253855KardiaPSI Balloon CatheterIntervention Tech, Inc. ; dba Corvention

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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