Cleared Traditional

VIDA PTV DILATATON CATHETER

K131002 · C.R. Bard, Inc. · Cardiovascular

Jul 2013

Decision

83d

Days

Class 2

Risk

About This 510(k) Submission

K131002 is an FDA 510(k) clearance for the VIDA PTV DILATATON CATHETER, a Pulmonary (pulmonic) Valvuloplasty Catheters/percutaneous Valvuloplasty Catheter (Class II — Special Controls, product code OMZ), submitted by C.R. Bard, Inc. (Tempe, US). The FDA issued a Cleared decision on July 2, 2013, 83 days after receiving the submission on April 10, 2013. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number	K131002 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 10, 2013
Decision Date	July 02, 2013
Days to Decision	83 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.