๐ง๐ฒ๐น๐ฒ๐๐ฎ๐ถ๐ฟ, ๐๐ป๐ฐ. ๐ฅ๐ฒ๐ฐ๐ฒ๐ถ๐๐ฒ๐ ๐๐๐ ๐ฑ๐ญ๐ฌ(๐ธ) ๐๐น๐ฒ๐ฎ๐ฟ๐ฎ๐ป๐ฐ๐ฒ ๐ณ๐ผ๐ฟ ๐๐ถ๐๐ฝ๐ผ๐๐ฎ๐ฏ๐น๐ฒ ๐๐๐ฒ๐ฎ ๐๐ ๐ฝ๐ถ๐ฟ๐ฎ๐๐ผ๐ฟ๐ ๐๐ถ๐น๐๐ฒ๐ฟ ๐ฎ๐ป๐ฑ ๐ช๐ฎ๐๐ฒ๐ฟ ๐ง๐ฟ๐ฎ๐ฝ
- jameszhou8
- May 8
- 2 min read
๐๐ฅ๐ฉ๐๐ก๐, ๐๐ โ ๐ ๐ฎ๐ ๐ด๐๐ต, ๐ฎ๐ฌ๐ฎ๐ฑ โย Telesair, Inc., an innovator in respiratory care technology, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the disposable Aveaโข expiratory filter and water trap.
This regulatory clearance is a significant step following Telesair's acquisition of the Aveaโข filter business from Vyaire Medical earlier this year. The clearance ensures the continued availability of this critical components for the widely used Vyaire Aveaโข ventilator system.
The Aveaโข expiratory filter and water trap are essential single-use accessories designed to protect both the patient and the ventilator hardware by effectively filtering expired gases and managing condensate during mechanical ventilation. Continued access to these FDA-cleared components is vital for hospitals and healthcare facilities relying on the Aveaโข ventilator platform to treat critically ill patients.
"Securing FDA 510(k) clearance for the Aveaโข expiratory filter and water trap underscores Telesair's commitment to supporting patients and clinicians," said Dr.ย Don Lin, CEO. "When we acquired this product line, our priority was to ensure a seamless transition for the hospitals that depend on the Aveaโข system. This clearance allows us to fulfill that commitment, helping to maintain high standards of care for vulnerable patients."
The acquisition and subsequent FDA clearance by Telesair prevent potential disruptions in the supply chain for these necessary ventilator accessories, allowing healthcare providers to continue utilizing their existing Vyaire Aveaโข ventilator fleets.
๐๐ฏ๐ผ๐๐ ๐ง๐ฒ๐น๐ฒ๐๐ฎ๐ถ๐ฟ, ๐๐ป๐ฐ. Telesair, Inc., based in Irvine, California, is an innovator in the respiratory care market, dedicated to developing advanced technology solutions to improve patient outcomes and support clinicians worldwide. The company focuses on creating high-quality, reliable medical devices for critical care environments.
For further information regarding the Avea filter please contactย Avea_filter@telesair.com