Cleared Traditional

BARD PTV DILATATION CATHETER

K122367 · C.R. Bard, Inc. · Cardiovascular

Nov 2012

Decision

88d

Days

Class 2

Risk

About This 510(k) Submission

K122367 is an FDA 510(k) clearance for the BARD PTV DILATATION 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 November 2, 2012, 88 days after receiving the submission on August 6, 2012. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number	K122367 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 06, 2012
Decision Date	November 02, 2012
Days to Decision	88 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.