Cleared Traditional

MULLINS-X PTV CATHETER

K102473 · NuMED, Inc. · Cardiovascular
Dec 2010
Decision
101d
Days
Class 2
Risk

About This 510(k) Submission

K102473 is an FDA 510(k) clearance for the MULLINS-X PTV CATHETER, 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 review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K102473 FDA.gov
FDA Decision Cleared 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

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.