TREO Abdominal Stent-Graft System 28-S2-11-080U

GUDID 08435761051954

Endovascular Stent-Graft System

Bolton Medical Inc.

Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft, non-medicated Abdominal aorta endovascular stent-graft, non-medicated Abdominal aorta endovascular stent-graft, non-medicated Abdominal aorta endovascular stent-graft, non-medicated Abdominal aorta endovascular stent-graft, non-medicated Abdominal aorta endovascular stent-graft, non-medicated Abdominal aorta endovascular stent-graft, non-medicated Abdominal aorta endovascular stent-graft, non-medicated Abdominal aorta endovascular stent-graft, non-medicated Abdominal aorta endovascular stent-graft, non-medicated Abdominal aorta endovascular stent-graft, non-medicated Abdominal aorta endovascular stent-graft, non-medicated Abdominal aorta endovascular stent-graft, non-medicated Abdominal aorta endovascular stent-graft, non-medicated Abdominal aorta endovascular stent-graft, non-medicated Abdominal aorta endovascular stent-graft, non-medicated Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft
Primary Device ID08435761051954
NIH Device Record Keya1683dda-16c7-4828-88ac-1ab78891dd7d
Commercial Distribution StatusIn Commercial Distribution
Brand NameTREO Abdominal Stent-Graft System
Version Model Number28-S2-11-080U
Catalog Number28-S2-11-080U
Company DUNS847424462
Company NameBolton Medical 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 Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Outer Diameter11 Millimeter
Length79 Millimeter
Catheter Gauge13 French
Outer Diameter11 Millimeter
Length79 Millimeter
Catheter Gauge13 French
Outer Diameter11 Millimeter
Length79 Millimeter
Catheter Gauge13 French
Outer Diameter11 Millimeter
Length79 Millimeter
Catheter Gauge13 French
Outer Diameter11 Millimeter
Length79 Millimeter
Catheter Gauge13 French
Outer Diameter11 Millimeter
Length79 Millimeter
Catheter Gauge13 French
Outer Diameter11 Millimeter
Length79 Millimeter
Catheter Gauge13 French
Outer Diameter11 Millimeter
Length79 Millimeter
Catheter Gauge13 French
Outer Diameter11 Millimeter
Length79 Millimeter
Catheter Gauge13 French
Outer Diameter11 Millimeter
Length79 Millimeter
Catheter Gauge13 French
Outer Diameter11 Millimeter
Length79 Millimeter
Catheter Gauge13 French
Outer Diameter11 Millimeter
Length79 Millimeter
Catheter Gauge13 French
Outer Diameter11 Millimeter
Length79 Millimeter
Catheter Gauge13 French
Outer Diameter11 Millimeter
Length79 Millimeter
Catheter Gauge13 French
Outer Diameter11 Millimeter
Length79 Millimeter
Catheter Gauge13 French
Outer Diameter11 Millimeter
Length79 Millimeter
Catheter Gauge13 French
Outer Diameter11 Millimeter
Length79 Millimeter
Catheter Gauge13 French
Outer Diameter11 Millimeter
Length79 Millimeter
Catheter Gauge13 French
Outer Diameter11 Millimeter
Length79 Millimeter
Catheter Gauge13 French
Outer Diameter11 Millimeter
Length79 Millimeter
Catheter Gauge13 French
Outer Diameter11 Millimeter
Length79 Millimeter
Catheter Gauge13 French
Outer Diameter11 Millimeter
Length79 Millimeter
Catheter Gauge13 French
Outer Diameter11 Millimeter
Length79 Millimeter
Catheter Gauge13 French
Outer Diameter11 Millimeter
Length79 Millimeter
Catheter Gauge13 French
Outer Diameter11 Millimeter
Length79 Millimeter
Catheter Gauge13 French
Outer Diameter11 Millimeter
Length79 Millimeter
Catheter Gauge13 French
Outer Diameter11 Millimeter
Length79 Millimeter
Catheter Gauge13 French
Outer Diameter11 Millimeter
Length79 Millimeter
Catheter Gauge13 French
Outer Diameter11 Millimeter
Length79 Millimeter
Catheter Gauge13 French
Outer Diameter11 Millimeter
Length79 Millimeter
Catheter Gauge13 French
Outer Diameter11 Millimeter
Length79 Millimeter
Catheter Gauge13 French
Outer Diameter11 Millimeter
Length79 Millimeter
Catheter Gauge13 French
Outer Diameter11 Millimeter
Length79 Millimeter
Catheter Gauge13 French
Outer Diameter11 Millimeter
Length79 Millimeter
Catheter Gauge13 French
Outer Diameter11 Millimeter
Length79 Millimeter
Catheter Gauge13 French
Outer Diameter11 Millimeter
Length79 Millimeter
Catheter Gauge13 French
Outer Diameter11 Millimeter
Length79 Millimeter
Catheter Gauge13 French
Outer Diameter11 Millimeter
Length79 Millimeter
Catheter Gauge13 French
Outer Diameter11 Millimeter
Length79 Millimeter
Catheter Gauge13 French
Outer Diameter11 Millimeter
Length79 Millimeter
Catheter Gauge13 French
Outer Diameter11 Millimeter
Length79 Millimeter
Catheter Gauge13 French
Outer Diameter11 Millimeter
Length79 Millimeter
Catheter Gauge13 French
Outer Diameter11 Millimeter
Length79 Millimeter
Catheter Gauge13 French
Outer Diameter11 Millimeter
Length79 Millimeter
Catheter Gauge13 French
Outer Diameter11 Millimeter
Length79 Millimeter
Catheter Gauge13 French
Outer Diameter11 Millimeter
Length79 Millimeter
Catheter Gauge13 French
Outer Diameter11 Millimeter
Length79 Millimeter
Catheter Gauge13 French
Outer Diameter11 Millimeter
Length79 Millimeter
Catheter Gauge13 French
Outer Diameter11 Millimeter
Length79 Millimeter
Catheter Gauge13 French
Outer Diameter11 Millimeter
Length79 Millimeter
Catheter Gauge13 French
Outer Diameter11 Millimeter
Length79 Millimeter
Catheter Gauge13 French
Outer Diameter11 Millimeter
Length79 Millimeter
Catheter Gauge13 French
Outer Diameter11 Millimeter
Length79 Millimeter
Catheter Gauge13 French
Outer Diameter11 Millimeter
Length79 Millimeter
Catheter Gauge13 French
Outer Diameter11 Millimeter
Length79 Millimeter
Catheter Gauge13 French
Outer Diameter11 Millimeter
Length79 Millimeter
Catheter Gauge13 French
Outer Diameter11 Millimeter
Length79 Millimeter
Catheter Gauge13 French
Outer Diameter11 Millimeter
Length79 Millimeter
Catheter Gauge13 French
Outer Diameter11 Millimeter
Length79 Millimeter
Catheter Gauge13 French
Outer Diameter11 Millimeter
Length79 Millimeter
Catheter Gauge13 French
Outer Diameter11 Millimeter
Length79 Millimeter
Catheter Gauge13 French
Outer Diameter11 Millimeter
Length79 Millimeter
Catheter Gauge13 French
Outer Diameter11 Millimeter
Length79 Millimeter
Catheter Gauge13 French
Outer Diameter11 Millimeter
Length79 Millimeter
Catheter Gauge13 French
Outer Diameter11 Millimeter
Length79 Millimeter
Catheter Gauge13 French
Outer Diameter11 Millimeter
Length79 Millimeter
Catheter Gauge13 French
Outer Diameter11 Millimeter
Length79 Millimeter
Catheter Gauge13 French
Outer Diameter11 Millimeter
Length79 Millimeter
Catheter Gauge13 French
Outer Diameter11 Millimeter
Length79 Millimeter
Catheter Gauge13 French
Outer Diameter11 Millimeter
Length79 Millimeter
Catheter Gauge13 French
Outer Diameter11 Millimeter
Length79 Millimeter
Catheter Gauge13 French
Outer Diameter11 Millimeter
Length79 Millimeter
Catheter Gauge13 French
Outer Diameter11 Millimeter
Length79 Millimeter
Catheter Gauge13 French
Outer Diameter11 Millimeter
Length79 Millimeter
Catheter Gauge13 French
Outer Diameter11 Millimeter
Length79 Millimeter
Catheter Gauge13 French
Outer Diameter11 Millimeter
Length79 Millimeter
Catheter Gauge13 French
Outer Diameter11 Millimeter
Length79 Millimeter
Catheter Gauge13 French
Outer Diameter11 Millimeter
Length79 Millimeter
Catheter Gauge13 French
Outer Diameter11 Millimeter
Length79 Millimeter
Catheter Gauge13 French
Outer Diameter11 Millimeter
Length79 Millimeter
Catheter Gauge13 French

Operating and Storage Conditions

Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS108435761051954 [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 Number2
Public Version Date2020-12-21
Device Publish Date2020-05-19

On-Brand Devices [TREO Abdominal Stent-Graft System ]

08435761052791Endovascular Stent-Graft System
08435761052784Endovascular Stent-Graft System
08435761052777Endovascular Stent-Graft System
08435761052760Endovascular Stent-Graft System
08435761052753Endovascular Stent-Graft System
08435761052746Endovascular Stent-Graft System
08435761052739Endovascular Stent-Graft System
08435761052722Endovascular Stent-Graft System
08435761052715Endovascular Stent-Graft System
08435761052708Endovascular Stent-Graft System
08435761052692Endovascular Stent-Graft System
08435761052685Endovascular Stent-Graft System
08435761052678Endovascular Stent-Graft System
08435761052661Endovascular Stent-Graft System
08435761052654Endovascular Stent-Graft System
08435761052647Endovascular Stent-Graft System
08435761052630Endovascular Stent-Graft System
08435761052623Endovascular Stent-Graft System
08435761052616Endovascular Stent-Graft System
08435761052609Endovascular Stent-Graft System
08435761052593Endovascular Stent-Graft System
08435761052586Endovascular Stent-Graft System
08435761052579Endovascular Stent-Graft System
08435761052562Endovascular Stent-Graft System
08435761052555Endovascular Stent-Graft System
08435761052548Endovascular Stent-Graft System
08435761052531Endovascular Stent-Graft System
08435761052524Endovascular Stent-Graft System
08435761052517Endovascular Stent-Graft System
08435761052500Endovascular Stent-Graft System
08435761052494Endovascular Stent-Graft System
08435761052487Endovascular Stent-Graft System
08435761052470Endovascular Stent-Graft System
08435761052463Endovascular Stent-Graft System
08435761052456Endovascular Stent-Graft System
08435761052449Endovascular Stent-Graft System
08435761052432Endovascular Stent-Graft System
08435761052425Endovascular Stent-Graft System
08435761052418Endovascular Stent-Graft System
08435761052401Endovascular Stent-Graft System
08435761052395Endovascular Stent-Graft System
08435761052388Endovascular Stent-Graft System
08435761052371Endovascular Stent-Graft System
08435761052364Endovascular Stent-Graft System
08435761052357Endovascular Stent-Graft System
08435761052340Endovascular Stent-Graft System
08435761052333Endovascular Stent-Graft System
08435761052326Endovascular Stent-Graft System
08435761052319Endovascular Stent-Graft System
08435761052302Endovascular Stent-Graft System

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