Summary of the Medical Device User Manual
The user manual provides instructions for use of the Cordis EXOSEAL TM Vascular Closure Device, a device designed for femoral artery puncture site closure, reducing times to hemostasis and ambulation.
The device consists of a Plug Applier and an absorbable Plug, which is fully enclosed in the distal portion of the Delivery Shaft. The device is intended for single use only and must be used with a French size-specific procedural Vascular Sheath Introducer.
The manual highlights the importance of following proper sterile technique during the procedure and provides guidance on device deployment, handling, and removal. It also warns against reusing or resterilizing the device.
The user manual includes information on the device’s performance in clinical trials and provides safety and effectiveness data from prospective, multi-center, randomized clinical trials.
Key Points
- The device is designed for femoral artery puncture site closure.
- The device must be used with a French size-specific procedural Vascular Sheath Introducer.
- The device is intended for single use only.
- The manual provides guidance on proper sterile technique during the procedure.
- The device’s performance and safety data are presented from clinical trials.
Manual:
Download: Cordis EXOSEAL TM Vascular Closure Device INSTRUCTIONS FOR USE
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