510(k) K071095

ASPIRA PLEURAL DRAINAGE SYSTEM by Bard Access Systems, Inc. — Product Code DWM

K071095 is an FDA 510(k) premarket notification submitted by Bard Access Systems, Inc. for the device "ASPIRA PLEURAL DRAINAGE SYSTEM". The FDA issued a decision of Substantially Equivalent on May 18, 2007. The device falls under product code DWM (Apparatus, Suction, Patient Care), a Class II device regulated under 21 CFR 870.5050. Bard Access Systems, Inc. has at least 10 other 510(k) clearances on record.