K102473 is an FDA 510(k) clearance for the MULLINS-X PTV CATHETER. This device is classified as a Pulmonary (pulmonic) Valvuloplasty Catheters/percutaneous Valvuloplasty Catheter (Class II - Special Controls, product code OMZ).
Submitted by NuMED, Inc. (Hopkinton, US). The FDA issued a Cleared decision on December 9, 2010, 101 days after receiving the submission on August 30, 2010.
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 | K102473 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 30, 2010 |
| Decision Date | December 09, 2010 |
| Days to Decision | 101 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. |