Cleared Special

NUMED COEFFICIENT PTV CATHETERS

K014124 · NuMED, Inc. · Cardiovascular
Jan 2002
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K014124 is an FDA 510(k) clearance for the NUMED COEFFICIENT PTV CATHETERS, 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 January 16, 2002, 30 days after receiving the submission on December 17, 2001. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K014124 FDA.gov
FDA Decision Cleared SESE
Date Received December 17, 2001
Decision Date January 16, 2002
Days to Decision 30 days
Submission Type Special
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.