Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Multistage Balloon Dilatation Catheter

K-Number: K222187 · 2023-03-01

ApplicantDongguan TT Medical, Inc.
Decision Date2023-03-01
Product CodeKTI
Advisory CommitteeEN
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 2023-03-01 under approval number K222187. The device is classified under product code KTI. It was reviewed by the EN 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 2023-03-01. It is manufactured by Dongguan TT Medical, Inc.. The 510(k) number is K222187.

When was Multistage Balloon Dilatation Catheter approved by the FDA?

Multistage Balloon Dilatation Catheter received FDA 510(k) clearance on 2023-03-01, under approval number K222187.

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 KTI.

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®) K222663MultiStage Balloon Dilatation Catheter K240967ValvuloPro Valvuloplasty Balloon Catheter K260437Valvuloplasty Balloon Catheter (ValvuloPro)

Related Devices (Code: KTI)

K161392Elation Pulmonary Balloon DilationMerit Medical Systems, Inc. K153484Dillard Airway Dilatation SystemIntuit Medical Products, LLC K152922ViziShot FLEXSpiration, Inc. K171232PeriView FLEXOlympus Surgical Technologies America K170759CRE Pulmonary Balloon Dilatation CatheterBoston Scientific Corporation K163469ViziShot 2 FLEXOlympus Surgical Technologies America

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.

↑