Ovation

Ovation 5X00419G01 Module

2025-07-10 Ovation 0
Email:plc@servomodule.com
  • Manufacturer:Ovation
  • Product Number:5X00419G01
  • Condition:brand new
  • Origin:USA
  • Stock:15
  • Payment Methods:T/T, PayPal, Western Union
  • Warranty:12 months
  • Lead Time:3-7 Working Days
  • Courier partners:DHL, UPS, TNT, FedEx and EMS.
  • Business hours:7*24
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Details
Ovation 5X00419G01

Ovation 5X00419G01 ModuleWestinghouse New In Stock

Introduction

The Ovation iX Abdominal Stent Graft System is for single patient use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or re-sterilization may compromise the structural integrity of the device and/or lead to device failure that may result in patient injury, illness or death. Reuse, reprocessing or re-sterilization may also create a risk of contamination of the device and/or cause patient infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient.

Polymer leaks are a unique potential risk of the Ovation device platform that have been reported postmarket. The complications of polymer leakage into the vasculature have ranged from transient hypotension to severe life-threatening anaphylactoid reactions, tissue necrosis and death. When polymer leaks occur, underfilling of the Ovation iX sealing rings have led to intraoperative Type Ia endoleaks and iliac limb complications that have required additional therapy. The risk of polymer leak should be carefully considered along with the risks associated with alternative treatment options when making personalized treatment decisions for those individuals who fall within the indicated patient population as defined by the Indications for Use.

Accurate fluoroscopic imaging is required during any endovascular procedure and for proper device deployment. Implantation of this device should occur in an operating room, endovascular suite, catheterization laboratory, or similar sterile environment, with appropriately trained personnel, and suitable equipment and imaging capabilities.

Ovation Products

4A00106H18 1X00102H01 1C31222G01
3A99266G01 1X00030H04 1C31219G01
3A99220G01 1X00030H02 1C31204G01
3A99190G01 1X00030H01 1C31203G01
3A99158G01 1X00024H01 WH1-2FF 1C31197G05
3A99132G02 1P00028G01 1C31197G01
1X00884H01 1C31238H01 1C31194G04
1X00781H01L 1C31234G01 1C31194G03
1X00707H06 1C31233G04 1C31194G01
1X00569H01 1C31232G03 1C31192G01
1X00529H23 1C31227G01 1C31189G01
1X00416H01 WH5-2FF 1X00188H01 4A00120H01

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