EDWARDS BALLOON CATHETER

Manufacturer : Edwards Lifesciences LLC

Brand : 23MM X 4CM X 130CM EDWARDS BALLOON CATHETER

MFG item # : 9350BC23

Catalog # : 9350BC23A

FDA Product Code Name : OZT

GMDN Term Name : Cardiac valvuloplasty catheter

Package quantity : N/A

Source	Chain of Custody	Credentialed	Rating	In Stock	Price	Quantity	Exp.	Lead times	Min. Quantity	Quantity Increment
Distributor			N/A	8 pack(s) of 1	89.00			1-2 days	1	1

Product classification

Product classification:

Balloon aortic valvuloplasty

Product code:

OZT

GTIN:

true

GMDN

Code:

Cardiac valvuloplasty catheter

Description:

A sterile flexible tube with an inflatable balloon designed to perform plastic or restorative surgery on a cardiac valve, i.e., for the dilatation of atrioventricular, aortic, and pulmonary trunk valves. It is typically used for the percutaneous dilatation of commissural fusion in stenotic mitral valves and for annular, cuspal, and calcific nodular fractures, to improve cuspal mobility in adult calcific aortic stenosis, and for leaflet tearing in pulmonic valve stenosis. It may also be used for percutaneous balloon pericardiotomy. This is a single-use device.

DEVICE

Single Use:

Otc:

Rx:

Device distribution status:

In Commercial Distribution

Device count:

Device kit:

Lot batch:

Expiration date:

STERILIZATION METHOD TYPES

Additional information

DEVICE SIZES

Device sizes type:

Device Size Text, specify

Device size text:

23 MILIMETER DIAMETER NOMINAL BALLOON DIAMETER

ENVIRONMENTAL CONDITIONS

Storage handling type:

Special Storage Condition, Specify

Storage handling special condition:

STORE IN A COOL, DRY PLACE

IDENTIFIERS

Device Id:

00690103191820

Device type:

Primary

Recall history

Recall Date:

Status:

Recall Number:

View FDA Recall:

Product Documents