Medical Tubing and Extrusion

Medical tubing and extrusion technologies

fda

Bluegrass Vascular Technologies wins de novo nod for ‘inside-out’ vascular access catheter

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Bluegrass Vascular Technologies announced that it won FDA de novo clearance for its Surfacer inside-out access catheter system. The Surfacer is designed to obtain central venous access through its inside-out approach, facilitating catheter insertion to the central venous system in people with upper body venous occlusions or other conditions that … [Read more...] about Bluegrass Vascular Technologies wins de novo nod for ‘inside-out’ vascular access catheter

FDA issues draft guidance on multi-use arthroscopy tubing sets

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The FDA has issued draft guidance on arthroscopy pump tubing sets intended for multiple-patient use. Clinicians often use a single source of irrigation fluid for multiple patients without replacing the source of irrigation fluid or replacing/reprocessing the irrigation tubing system between patients.  These devices are designed to deliver … [Read more...] about FDA issues draft guidance on multi-use arthroscopy tubing sets

Innovative Health lands another catheter reprocessing clearance

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Innovative Health said today that it has received FDA clearance to reprocess the Biosense Webster PentaRay Nav eco high-density mapping catheter for reuse. The clearance is the latest allowing Scottsdale, Ariz.-based Innovative Health to reprocess catheters. The FDA cleared it in 2018 to reprocess St. Jude Medical’s Advisor FL, Medtronic’s Torqr … [Read more...] about Innovative Health lands another catheter reprocessing clearance

2 deaths reported in recall of 6 million Teleflex endotracheal tubes

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Teleflex (NYSE:TFX) is recalling multiple models of its Hudson RCI Sheridan and Sheridan endotracheal tubes due to complaints of the Sheridan connector disconnecting from the breathing circuit. Two deaths and one injury have been reported to the company, according to the FDA. Each of the more than 6 million recalled tracheal tubes includes an … [Read more...] about 2 deaths reported in recall of 6 million Teleflex endotracheal tubes

EO plant shutdown leads to pediatric breathing tube shortage

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The February shutdown of an ethylene oxide (EO) sterilization plant has produced the first temporary medical device shortage, according to the FDA. The device in short supply is the Bivona tracheostomy tube manufactured by Smiths Medical and used by many pediatric patients. The FDA anticipates the tube will be made available again the week of … [Read more...] about EO plant shutdown leads to pediatric breathing tube shortage

FDA clears Safe Medical Design’s urethral catheter

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Safe Medical Design (San Francisco) said that FDA has cleared its Signal Catheter for commercialization in the United States. The 100% silicone foley catheter features a novel hub design allowing the catheter to reduce excessive balloon pressure in the event the catheter is improperly placed. Each year in the United States there are as many as … [Read more...] about FDA clears Safe Medical Design’s urethral catheter

FDA clears Imperative Care’s stroke treatment catheters

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Stroke-treatment startup Imperative Care (Campbell, Calif.) said it has landed FDA approval for its first line of access catheters. Access to brain blood vessels can be challenging because of the brain’s highly complex and twisted vascular structure. The catheters were designed to deliver interventional treatments during minimally invasive … [Read more...] about FDA clears Imperative Care’s stroke treatment catheters