Ovation iX Abdominal Stent Graft System - The TriVascular® Ovation iX™ Abdominal Stent - Trivascular, Inc.

Duns Number:826179819

Device Description: The TriVascular® Ovation iX™ Abdominal Stent Graft System is an endovascular device delive

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More Product Details

Catalog Number

TV-AB2380-J

Brand Name

Ovation iX Abdominal Stent Graft System

Version/Model Number

Aortic Body

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

MR Conditional

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

P120006

Product Code Details

Product Code

MIH

Product Code Name

System, Endovascular Graft, Aortic Aneurysm Treatment

Device Record Status

Public Device Record Key

6553119c-080f-45ba-97d5-8d8689341b2a

Public Version Date

April 08, 2022

Public Version Number

6

DI Record Publish Date

August 06, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TRIVASCULAR, INC." Characteristics
Device Class Device Class Description No of Devices
3 A medical device with high risk that requires premarket approval 42