K153069 is an FDA 510(k) clearance for the Edwards Balloon Catheter. This device is classified as 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 FDA review panel. Regulated under 21 CFR 870.1250. 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..
| 510(k) Number | K153069 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| 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. |