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

FDA 510(k)

Edwards Balloon Catheter

K-Number: K153069 · 2016-01-07

ApplicantEdwards Lifesciences
Decision Date2016-01-07
Product CodeOMZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Edwards Balloon Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Edwards Lifesciences. It received FDA 510(k) clearance on 2016-01-07 under 510(k) number K153069. The device is classified under product code OMZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Edwards Balloon Catheter?

Edwards Balloon Catheter is a medical device that received FDA 510(k) clearance on 2016-01-07. The listed applicant is Edwards Lifesciences. The 510(k) number is K153069.

When did Edwards Balloon Catheter receive FDA 510(k) clearance?

Edwards Balloon Catheter received FDA 510(k) clearance on 2016-01-07, under 510(k) number K153069.

Who is the listed applicant for Edwards Balloon Catheter?

The FDA 510(k) record lists Edwards Lifesciences as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Edwards Balloon Catheter?

The FDA product code for Edwards Balloon Catheter is OMZ.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT05172960ALLIANCE: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart ValveRECRUITINGNCT05172973ALLIANCE AVIV: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve in Failing Aortic Bioprosthetic ValvesRECRUITINGNCT02744677COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve DysfunctionRECRUITINGNCT03230747SAPIEN M3 EFS: Early Feasibility Study of the Edwards SAPIEN M3 System for the Treatment of Mitral RegurgitationACTIVE_NOT_RECRUITINGNCT03706833Edwards PASCAL CLASP IID/IIF Pivotal Clinical TrialACTIVE_NOT_RECRUITINGNCT03745313Edwards CLASP TR EFSCOMPLETED

Other records listing Edwards Lifesciences as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

PMA P230013Percutaneously Delivered Prostheses and Tricuspid ValvesPMA P860057replacement Heart-valvePMA P250019Prosthesis, mitral valve, percutaneously deliveredPMA P220003Mitral valve repair devicesPMA P200015Pulmonary valve prosthesis percutaneously deliveredPMA P150048heart-valve, non-allograft tissue

View all 81 devices →

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.

↑