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087 Balloon Guide Catheter System

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Generic:Catheter, Percutaneous
Manufacturer:Q'Apel, Q'Apel Medical, LLC
Drug Classes:Not Available
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  • No Preview Available

087 Balloon Guide Catheter System

Generic:Catheter, Percutaneous
Manufacturer:Q'Apel, Q'Apel Medical, LLC
Drug Classes:Not Available
Reps:
Rep 1Signup or Login to view Reps
Rep 2Signup or Login to view Reps
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Synopsis
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DescriptionIndication and Usage
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Synopsis
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087 Balloon Guide Catheter System
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Disclaimer: The synopsis and product information provided on Alpha.MD are derived from openFDA data and are for informational purposes only. This information may not be comprehensive, accurate, or up-to-date. Clinicians should exercise their own professional judgment in interpreting and using this information, and consult the official prescribing information for the most accurate and current details.
Description

A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

Indication and Usage

The 087 Balloon Guide Catheter System is indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neurovasculature. The balloon provides temporary vascular occlusion during such procedures. The 087 Balloon Guide Catheter System is also indicated for use as a conduit for retrieval devices.

Approval History
FDA approved 2019
Includes history for all formulations of adalimumab
October 31, 2019
(Type 2 New Active Ingredient and Type 4 New Combination)
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