Cleared Traditional

Edwards Balloon Catheter

K153069 · Edwards Lifesciences · Cardiovascular

Jan 2016

Decision

77d

Days

Class 2

Risk

About This 510(k) Submission

K153069 is an FDA 510(k) clearance for the Edwards Balloon Catheter, a Pulmonary (pulmonic) Valvuloplasty Catheters/percutaneous Valvuloplasty Catheter (Class II — Special Controls, product code OMZ), submitted by Edwards Lifesciences (Irvine, US). The FDA issued a Cleared decision on January 7, 2016, 77 days after receiving the submission on October 22, 2015. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number	K153069 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 22, 2015
Decision Date	January 07, 2016
Days to Decision	77 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	OMZ — Pulmonary (pulmonic) Valvuloplasty Catheters/percutaneous Valvuloplasty Catheter
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.1250
Definition	Catheter Is Used For Percutaneous Transluminal Or Balloon Valvuloplasty (ptv) Of The Pulmonary (pulmonic) Valve. Used On Patients With Isolated Pulmonary Stenosis And Also On Patients With Valvular Pulmonary Stenosis With Other Minor Congenital Heart Disease That Does Not Require Surgical Intervention.