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)

Elation Pulmonary Balloon Dilation

K-Number: K161392 · 2016-09-01

ApplicantMerit Medical Systems, Inc.
Decision Date2016-09-01
Product CodeKTI
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Elation Pulmonary Balloon Dilation is a medical device manufactured by Merit Medical Systems, Inc.. It received FDA 510(k) clearance on 2016-09-01 under approval number K161392. 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 Elation Pulmonary Balloon Dilation?

Elation Pulmonary Balloon Dilation is a medical device that received FDA 510(k) clearance on 2016-09-01. It is manufactured by Merit Medical Systems, Inc.. The 510(k) number is K161392.

When was Elation Pulmonary Balloon Dilation approved by the FDA?

Elation Pulmonary Balloon Dilation received FDA 510(k) clearance on 2016-09-01, under approval number K161392.

What company makes Elation Pulmonary Balloon Dilation?

Elation Pulmonary Balloon Dilation is manufactured by Merit Medical Systems, Inc..

What is the FDA product code for Elation Pulmonary Balloon Dilation?

The FDA product code for Elation Pulmonary Balloon Dilation is KTI.

Related Clinical Trials

NCT05147363 Shockwave: Disruption for A Better Fit WITHDRAWN NCT07599826 Active vs. Passive VR During Office-based ENT Procedures NOT_YET_RECRUITING NCT07587541 Low-VOLTage Area-Guided Catheter Ablation and SVC Isolation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 NCT05591118 Pulmonary Embolism - Thrombus Removal With Catheter-Directed Therapy 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 NCT07435532 Comparative Effects of Breather Device and Incentive Spirometer in Patients With COPD NOT_YET_RECRUITING

Other Devices by Merit Medical Systems, Inc.

K161921SwiftNINJA Microcatheter K162777Squirt Fluid Delivery System K160107DiamondTOUCH Inflation Device and Fluid Dispensing Syringe K151967Centros Long-Term Hemodialysis Catheter, CentrosFLO Long-Term Hemodialysis Catheter K153337Corvocet Biopsy System K153672basixTOUCH40 Inflation Syringe

View all 65 devices →

Related Devices (Code: KTI)

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 K181193PeriView 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.

↑