OMZ · Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter
Cardiovascular · 21 CFR 870.1250 · Class 2
Overview
| Product Code | OMZ |
|---|---|
| Device Name | Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter |
| Regulation | 21 CFR 870.1250 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
Identification
A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (5 of 5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K153069 | Edwards Balloon Catheter | Edwards Lifesciences | Jan 7, 2016 | SESE |
| K131002 | VIDA PTV DILATATON CATHETER | C.R. Bard, Inc. | Jul 2, 2013 | SESE |
| K122367 | BARD PTV DILATATION CATHETER | C.R. Bard, Inc. | Nov 2, 2012 | SESE |
| K102473 | MULLINS-X PTV CATHETER | NuMED, Inc. | Dec 9, 2010 | SESE |
| K014124 | NUMED COEFFICIENT PTV CATHETERS | NuMED, Inc. | Jan 16, 2002 | SESE |
Top Applicants
- C.R. Bard, Inc. — 2 clearances
- NuMED, Inc. — 2 clearances
- Edwards Lifesciences — 1 clearance
