Product code OMZ— Cardiovascular

BARD PTV DILATATION CATHETER

Classification name: Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter
Device class: Class 2
Regulation: 21 CFR 870.1250
Advisory panel: Cardiovascular
Total cleared: 5
First cleared: 2002-01-16
Most recent: 2016-01-07

FDA classification 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.”
— U.S. Food and Drug Administration, device classification record for product code OMZ under 21 CFR 870.1250, via openFDA

Market context for product code OMZ

FDA has cleared 5 devices under product code OMZ between 2002 and 2016, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

20161 clearance
20131 clearance
20121 clearance
20101 clearance
20021 clearance

Top applicants under product code OMZ

NuMED, Inc.2 clearances
C.R. Bard, Inc.2 clearances
Edwards Lifesciences1 clearance

Recent clearances under product code OMZ

K153069 — Edwards Balloon CatheterEdwards Lifesciences·2016-01-07
K131002 — VIDA PTV DILATATON CATHETERC.R. Bard, Inc.·2013-07-02
K122367 — BARD PTV DILATATION CATHETERC.R. Bard, Inc.·2012-11-02
K102473 — MULLINS-X PTV CATHETERNuMED, Inc.·2010-12-09
K014124 — NUMED COEFFICIENT PTV CATHETERSNuMED, Inc.·2002-01-16

Data sourced from openFDA. This site is unofficial and independent of the FDA.