510(k) K191909

HepaShield Bacterial Viral Breathing System Filter by Flexicare Medical Limited. — Product Code CAH

K191909 is an FDA 510(k) premarket notification submitted by Flexicare Medical Limited. for the device "HepaShield Bacterial Viral Breathing System Filter". The FDA issued a decision of Substantially Equivalent on March 23, 2020. The device falls under product code CAH (Filter, Bacterial, Breathing-Circuit), a Class II device regulated under 21 CFR 868.5260. Flexicare Medical Limited. has at least 7 other 510(k) clearances on record.