Product code OMZ

Device name: Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter
Medical specialty: Cardiovascular
Device class: 2
Regulation number: 870.1250
Review panel: CV
Implant: N
Life sustaining/supporting: N
GMP exempt: N
Third party review: N
Summary malfunction reporting: Eligible
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.
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K153069	Edwards Balloon Catheter	Edwards Lifesciences	2016-01-07
K131002	VIDA PTV DILATATON CATHETER	C.R. Bard, Inc.	2013-07-02
K122367	BARD PTV DILATATION CATHETER	C.R. Bard, Inc.	2012-11-02
K102473	MULLINS-X PTV CATHETER	NuMED, Inc.	2010-12-09
K014124	NUMED COEFFICIENT PTV CATHETERS	NuMED, Inc.	2002-01-16

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
00801741090875	VIDA	Bard Peripheral Vascular, Inc.	2016-09-16
00801741090981	VIDA	Bard Peripheral Vascular, Inc.	2016-09-16
00801741090974	VIDA	Bard Peripheral Vascular, Inc.	2016-09-16
00801741090967	VIDA	Bard Peripheral Vascular, Inc.	2016-09-16
00801741090950	VIDA	Bard Peripheral Vascular, Inc.	2016-09-16
00801741090943	VIDA	Bard Peripheral Vascular, Inc.	2016-09-16
00801741090936	VIDA	Bard Peripheral Vascular, Inc.	2016-09-16
00801741090929	VIDA	Bard Peripheral Vascular, Inc.	2016-09-16
00801741090912	VIDA	Bard Peripheral Vascular, Inc.	2016-09-16
00801741090905	VIDA	Bard Peripheral Vascular, Inc.	2016-09-16
00801741090899	VIDA	Bard Peripheral Vascular, Inc.	2016-09-16
00801741090882	VIDA	Bard Peripheral Vascular, Inc.	2016-09-16
00801741090868	VIDA	Bard Peripheral Vascular, Inc.	2016-09-16
00801741090851	VIDA	Bard Peripheral Vascular, Inc.	2016-09-16
00801741090844	VIDA	Bard Peripheral Vascular, Inc.	2016-09-16
00801741090837	VIDA	Bard Peripheral Vascular, Inc.	2016-09-16
00801741090820	VIDA	Bard Peripheral Vascular, Inc.	2016-09-16
00801741090813	VIDA	Bard Peripheral Vascular, Inc.	2016-09-16
00801741090806	VIDA	Bard Peripheral Vascular, Inc.	2016-09-16
00801741090790	VIDA	Bard Peripheral Vascular, Inc.	2016-09-16
00690103191813	20MM X 4CM X 130CM EDWARDS BALLOON CATHETER	Edwards Lifesciences LLC	2015-12-01
00690103194333	EDWARDS BALLOON CATHETER	Edwards Lifesciences LLC	2015-12-01
00690103193459	25MM X 4CM X 130CM EDWARDS BALLOON CATHETER	Edwards Lifesciences LLC	2015-12-01
00690103191820	23MM X 4CM X 130CM EDWARDS BALLOON CATHETER	Edwards Lifesciences LLC	2015-12-01

Product code OMZ

Related 510(k) Records#

Related GUDID Devices#