OMZ · Class II · 21 CFR 870.1250

FDA Product Code OMZ: Pulmonary (pulmonic) Valvuloplasty Catheters/percutaneous Valvuloplasty Catheter

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.

Leading manufacturers include NuMED, Inc. and C.R. Bard, Inc..

5
Total
5
Cleared
76d
Avg days
2002
Since

FDA 510(k) Cleared Pulmonary (pulmonic) Valvuloplasty Catheters/percutaneous Valvuloplasty Catheter Devices (Product Code OMZ)

5 devices
1–5 of 5
Cleared Jul 02, 2013
VIDA PTV DILATATON CATHETER
K131002
C.R. Bard, Inc.
Cardiovascular · 83d
Cleared Nov 02, 2012
BARD PTV DILATATION CATHETER
K122367
C.R. Bard, Inc.
Cardiovascular · 88d
Cleared Dec 09, 2010
MULLINS-X PTV CATHETER
K102473
NuMED, Inc.
Cardiovascular · 101d
Cleared Jan 16, 2002
NUMED COEFFICIENT PTV CATHETERS
K014124
NuMED, Inc.
Cardiovascular · 30d

About Product Code OMZ - Regulatory Context