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510(k) Data Aggregation
(94 days)
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(197 days)
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(178 days)
This product is intended to be used in combination with compatible colonoscopes to maintain the field of view during endoscopic procedures such as mucosal resection.
This product needs to be cut and connected to the endoscope tip of 9mm to 14mm, and medical tape needs to be prepared in advance to fix it into a cylindrical shape.
This product is intended to be attached to an endoscope.
The Disposable Distal End Tape Hood is installed at the tip of the endoscope to assist the endoscope in a clearer observation. It can push away the mucosa and keep a certain distance between the lens and the mucosa, thus maintaining the field of view.
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(30 days)
The Paragonix BAROguard is intended to be used for the static hypothermic preservation of lungs during transportation and eventual transplantation into a recipient using cold storage solutions indicated for use with the lungs.
The intended organ storage time for BAROguard is up to 8 hours.
Donor lungs exceeding clinically accepted static hypothermic preservation times should be evaluated by the transplant surgeon to determine transplantability in accordance with accepted clinical guidelines and in the best medical interest of the intended recipient.
Note: Partial lungs can be transported via BAROguard by packaging lungs per institutional protocol and UNOS guidelines.
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