FDA Clears 410 Medical’s Rapid-Infusion Device for Blood
410 Medical has earned an additional 510(k) clearance from the FDA for its LifeFlow rapid- infusion device, allowing it to be used to deliver blood and blood components.
The hand-operated infusion gun can be set up in less than two minutes and is able to deliver 500 ml of fluid in less than two-and-a-half minutes through a 20g IV catheter, according to the company.
The device delivers 10ml increments of fluid with each pull of the trigger and automatically refills when the handle is released. It previously received agency clearance for delivering crystalloid and colloid fluids.