Ovation iX Iliac Stent Graft TV-IL142880-J

GUDID M701TVIL142880J1

The TriVascular® Ovation Prime® Abdominal Stent Graft System with the Ovation iX Iliac Stent Graft is an endovascular device delivered via a small diameter catheter to treat abdominal aortic aneurysms (AAAs). The stent graft is designed to reline the diseased vasculature, providing an endovascular blood conduit for isolating the aneurysm from the high pressure flow of blood, thereby reducing the risk of rupture. The stent graft is a modular configuration comprised of an aortic body section, iliac limbs, and iliac extensions as required. The TriVascular Ovation Prime Abdominal Stent Graft System with the Ovation iX Iliac Stent Graft includes, an Aortic Body Stent Graft and delivery catheter, Iliac Limb Stent Grafts and delivery catheters, Iliac Extension Stent Grafts and delivery catheters, as required, a Fill Polymer Kit, and an Autoinjector.

Trivascular, Inc.

Abdominal aorta endovascular stent-graft
Primary Device IDM701TVIL142880J1
NIH Device Record Keyd4787d61-6f4e-4bbf-bc28-0729bd50a1e4
Commercial Distribution StatusIn Commercial Distribution
Brand NameOvation iX Iliac Stent Graft
Version Model NumberIliac Limb
Catalog NumberTV-IL142880-J
Company DUNS826179819
Company NameTrivascular, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Catheter Gauge15 French
Length80 Millimeter
Outer Diameter28 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge15 French
Length80 Millimeter
Outer Diameter28 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge15 French
Length80 Millimeter
Outer Diameter28 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge15 French
Length80 Millimeter
Outer Diameter28 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge15 French
Length80 Millimeter
Outer Diameter28 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge15 French
Length80 Millimeter
Outer Diameter28 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge15 French
Length80 Millimeter
Outer Diameter28 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge15 French
Length80 Millimeter
Outer Diameter28 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge15 French
Length80 Millimeter
Outer Diameter28 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge15 French
Length80 Millimeter
Outer Diameter28 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge15 French
Length80 Millimeter
Outer Diameter28 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge15 French
Length80 Millimeter
Outer Diameter28 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge15 French
Length80 Millimeter
Outer Diameter28 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge15 French
Length80 Millimeter
Outer Diameter28 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge15 French
Length80 Millimeter
Outer Diameter28 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge15 French
Length80 Millimeter
Outer Diameter28 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge15 French
Length80 Millimeter
Outer Diameter28 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge15 French
Length80 Millimeter
Outer Diameter28 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge15 French
Length80 Millimeter
Outer Diameter28 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge15 French
Length80 Millimeter
Outer Diameter28 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge15 French
Length80 Millimeter
Outer Diameter28 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge15 French
Length80 Millimeter
Outer Diameter28 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge15 French
Length80 Millimeter
Outer Diameter28 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge15 French
Length80 Millimeter
Outer Diameter28 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge15 French
Length80 Millimeter
Outer Diameter28 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge15 French
Length80 Millimeter
Outer Diameter28 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge15 French
Length80 Millimeter
Outer Diameter28 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge15 French
Length80 Millimeter
Outer Diameter28 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge15 French
Length80 Millimeter
Outer Diameter28 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge15 French
Length80 Millimeter
Outer Diameter28 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge15 French
Length80 Millimeter
Outer Diameter28 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge15 French
Length80 Millimeter
Outer Diameter28 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge15 French
Length80 Millimeter
Outer Diameter28 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge15 French
Length80 Millimeter
Outer Diameter28 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge15 French
Length80 Millimeter
Outer Diameter28 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge15 French
Length80 Millimeter
Outer Diameter28 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge15 French
Length80 Millimeter
Outer Diameter28 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge15 French
Length80 Millimeter
Outer Diameter28 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge15 French
Length80 Millimeter
Outer Diameter28 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge15 French
Length80 Millimeter
Outer Diameter28 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge15 French
Length80 Millimeter
Outer Diameter28 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge15 French
Length80 Millimeter
Outer Diameter28 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge15 French
Length80 Millimeter
Outer Diameter28 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge15 French
Length80 Millimeter
Outer Diameter28 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge15 French
Length80 Millimeter
Outer Diameter28 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge15 French
Length80 Millimeter
Outer Diameter28 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge15 French
Length80 Millimeter
Outer Diameter28 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge15 French
Length80 Millimeter
Outer Diameter28 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge15 French
Length80 Millimeter
Outer Diameter28 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge15 French
Length80 Millimeter
Outer Diameter28 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge15 French
Length80 Millimeter
Outer Diameter28 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge15 French
Length80 Millimeter
Outer Diameter28 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge15 French
Length80 Millimeter
Outer Diameter28 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge15 French
Length80 Millimeter
Outer Diameter28 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge15 French
Length80 Millimeter
Outer Diameter28 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge15 French
Length80 Millimeter
Outer Diameter28 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge15 French
Length80 Millimeter
Outer Diameter28 Millimeter
Outer Diameter14 Millimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM701TVIL142880J1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MIHSystem, Endovascular Graft, Aortic Aneurysm Treatment

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-12-21
Device Publish Date2015-03-05

On-Brand Devices [Ovation iX Iliac Stent Graft]

M701TVIL142880J1The TriVascular® Ovation Prime® Abdominal Stent Graft System with the Ovation iX Iliac Stent G
M701TVIL1428160J1The TriVascular® Ovation Prime® Abdominal Stent Graft System with the Ovation iX Iliac Stent G
M701TVIL1428140J1The TriVascular® Ovation Prime® Abdominal Stent Graft System with the Ovation iX Iliac Stent G
M701TVIL1428120J1The TriVascular® Ovation Prime® Abdominal Stent Graft System with the Ovation iX Iliac Stent G
M701TVIL1428100J1The TriVascular® Ovation Prime® Abdominal Stent Graft System with the Ovation iX Iliac Stent G
M701TVIL142280J1The TriVascular® Ovation Prime® Abdominal Stent Graft System with the Ovation iX Iliac Stent G
M701TVIL1422160J1The TriVascular® Ovation Prime® Abdominal Stent Graft System with the Ovation iX Iliac Stent G
M701TVIL1422140J1The TriVascular® Ovation Prime® Abdominal Stent Graft System with the Ovation iX Iliac Stent G
M701TVIL1422120J1The TriVascular® Ovation Prime® Abdominal Stent Graft System with the Ovation iX Iliac Stent G
M701TVIL1422100J1The TriVascular® Ovation Prime® Abdominal Stent Graft System with the Ovation iX Iliac Stent G
M701TVIL141880J1The TriVascular® Ovation Prime® Abdominal Stent Graft System with the Ovation iX Iliac Stent G
M701TVIL1418160J1The TriVascular® Ovation Prime® Abdominal Stent Graft System with the Ovation iX Iliac Stent G
M701TVIL1418140J1The TriVascular® Ovation Prime® Abdominal Stent Graft System with the Ovation iX Iliac Stent G
M701TVIL1418120J1The TriVascular® Ovation Prime® Abdominal Stent Graft System with the Ovation iX Iliac Stent G
M701TVIL1418100J1The TriVascular® Ovation Prime® Abdominal Stent Graft System with the Ovation iX Iliac Stent G
M701TVIL141680J1The TriVascular® Ovation Prime® Abdominal Stent Graft System with the Ovation iX Iliac Stent G
M701TVIL1416160J1The TriVascular® Ovation Prime® Abdominal Stent Graft System with the Ovation iX Iliac Stent G
M701TVIL1416140J1The TriVascular® Ovation Prime® Abdominal Stent Graft System with the Ovation iX Iliac Stent G
M701TVIL1416120J1The TriVascular® Ovation Prime® Abdominal Stent Graft System with the Ovation iX Iliac Stent G
M701TVIL1416100J1The TriVascular® Ovation Prime® Abdominal Stent Graft System with the Ovation iX Iliac Stent G
M701TVIL141480J1The TriVascular® Ovation Prime® Abdominal Stent Graft System with the Ovation iX Iliac Stent G
M701TVIL1414160J1The TriVascular® Ovation Prime® Abdominal Stent Graft System with the Ovation iX Iliac Stent G
M701TVIL1414140J1The TriVascular® Ovation Prime® Abdominal Stent Graft System with the Ovation iX Iliac Stent G
M701TVIL1414120J1The TriVascular® Ovation Prime® Abdominal Stent Graft System with the Ovation iX Iliac Stent G
M701TVIL1414100J1The TriVascular® Ovation Prime® Abdominal Stent Graft System with the Ovation iX Iliac Stent G
M701TVIL141280J1The TriVascular® Ovation Prime® Abdominal Stent Graft System with the Ovation iX Iliac Stent G
M701TVIL1412160J1The TriVascular® Ovation Prime® Abdominal Stent Graft System with the Ovation iX Iliac Stent G
M701TVIL1412140J1The TriVascular® Ovation Prime® Abdominal Stent Graft System with the Ovation iX Iliac Stent G
M701TVIL1412120J1The TriVascular® Ovation Prime® Abdominal Stent Graft System with the Ovation iX Iliac Stent G
M701TVIL1412100J1The TriVascular® Ovation Prime® Abdominal Stent Graft System with the Ovation iX Iliac Stent G
M701TVIL141080J1The TriVascular® Ovation Prime® Abdominal Stent Graft System with the Ovation iX Iliac Stent G
M701TVIL1410160J1The TriVascular® Ovation Prime® Abdominal Stent Graft System with the Ovation iX Iliac Stent G
M701TVIL1410140J1The TriVascular® Ovation Prime® Abdominal Stent Graft System with the Ovation iX Iliac Stent G
M701TVIL1410120J1The TriVascular® Ovation Prime® Abdominal Stent Graft System with the Ovation iX Iliac Stent G
M701TVIL1410100J1The TriVascular® Ovation Prime® Abdominal Stent Graft System with the Ovation iX Iliac Stent G
M701TVEX282845J1The TriVascular® Ovation Prime® Abdominal Stent Graft System with the Ovation iX Iliac Stent G
M701TVEX222245J1The TriVascular® Ovation Prime® Abdominal Stent Graft System with the Ovation iX Iliac Stent G
M701TVEX181845J1The TriVascular® Ovation Prime® Abdominal Stent Graft System with the Ovation iX Iliac Stent G
M701TVEX161645J1The TriVascular® Ovation Prime® Abdominal Stent Graft System with the Ovation iX Iliac Stent G
M701TVEX141445J1The TriVascular® Ovation Prime® Abdominal Stent Graft System with the Ovation iX Iliac Stent G
M701TVEX121245J1The TriVascular® Ovation Prime® Abdominal Stent Graft System with the Ovation iX Iliac Stent G
M701TVEX101045J1The TriVascular® Ovation Prime® Abdominal Stent Graft System with the Ovation iX Iliac Stent G

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.