510(k) K220311

Cardiovascular Angiography System by Allengers Medical Systems Limited — Product Code OWB

K220311 is an FDA 510(k) premarket notification submitted by Allengers Medical Systems Limited for the device "Cardiovascular Angiography System". The FDA issued a decision of Substantially Equivalent on May 3, 2022. The device falls under product code OWB (Interventional Fluoroscopic X-Ray System), a Class II device regulated under 21 CFR 892.1650. Allengers Medical Systems Limited has at least 7 other 510(k) clearances on record.