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FDA 510(k)

MultiStage Balloon Dilatation Catheter

K-Number: K222663 · 2023-03-09

ApplicantDongguan TT Medical, Inc.
Decision Date2023-03-09
Product CodeFGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MultiStage Balloon Dilatation Catheter is a medical device manufactured by Dongguan TT Medical, Inc.. It received FDA 510(k) clearance on 2023-03-09 under approval number K222663. The device is classified under product code FGE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MultiStage Balloon Dilatation Catheter?

MultiStage Balloon Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2023-03-09. It is manufactured by Dongguan TT Medical, Inc.. The 510(k) number is K222663.

When was MultiStage Balloon Dilatation Catheter approved by the FDA?

MultiStage Balloon Dilatation Catheter received FDA 510(k) clearance on 2023-03-09, under approval number K222663.

What company makes MultiStage Balloon Dilatation Catheter?

MultiStage Balloon Dilatation Catheter is manufactured by Dongguan TT Medical, Inc..

What is the FDA product code for MultiStage Balloon Dilatation Catheter?

The FDA product code for MultiStage Balloon Dilatation Catheter is FGE.

Related Clinical Trials

NCT07614100 Cerebral Microembolization During Transcatheter Aortic Valve Implantation: Comparing Balloon-expandable and Self-expanding Valves NOT_YET_RECRUITING 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

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®) K222187Multistage Balloon Dilatation Catheter K240967ValvuloPro Valvuloplasty Balloon Catheter K260437Valvuloplasty Balloon Catheter (ValvuloPro)

Related Devices (Code: FGE)

K163018Zilver 635 Biliary StentCook Ireland, Ltd. K162404Express SD Biliary Monorail Premounted Stent SystemBoston Scientific Corporation K161203Soehendra Stent RetrieverWilson-Cook Medical, Inc. K150487X-Suit NIR Biliary Metallic StentMedinol, Ltd. K171548Cotton Graduated Dilation Catheter, Fusion Biliary Dilation Catheter, Soehendra Biliary Dilation Catheter, Geenen Graduated Dilation CatheterWilson-Cook Medical, Inc. K172520CRE RX Biliary Balloon Dilatation CatheterBoston Scientific Corporation

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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