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FDA 510(k)

Elation Pulmonary Balloon Dilation Catheter

K-Number: K213434 · 2022-03-08

ApplicantMerit Medical Systems, Inc.
Decision Date2022-03-08
Product CodeKTI
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Elation Pulmonary Balloon Dilation Catheter is a medical device manufactured by Merit Medical Systems, Inc.. It received FDA 510(k) clearance on 2022-03-08 under approval number K213434. 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 Catheter?

Elation Pulmonary Balloon Dilation Catheter is a medical device that received FDA 510(k) clearance on 2022-03-08. It is manufactured by Merit Medical Systems, Inc.. The 510(k) number is K213434.

When was Elation Pulmonary Balloon Dilation Catheter approved by the FDA?

Elation Pulmonary Balloon Dilation Catheter received FDA 510(k) clearance on 2022-03-08, under approval number K213434.

What company makes Elation Pulmonary Balloon Dilation Catheter?

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

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

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

Related Clinical Trials

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Other Devices by Merit Medical Systems, Inc.

K161921SwiftNINJA Microcatheter K162777Squirt Fluid Delivery System K161392Elation Pulmonary Balloon Dilation K160107DiamondTOUCH Inflation Device and Fluid Dispensing Syringe K151967Centros Long-Term Hemodialysis Catheter, CentrosFLO Long-Term Hemodialysis Catheter K153337Corvocet Biopsy System

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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.

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