510(k) K011831

MODIFICATION TO PLEURX PLEURAL CATHETER AND DRAINAGE KITS by Denver Biomedical, Inc. — Product Code DWM

K011831 is an FDA 510(k) premarket notification submitted by Denver Biomedical, Inc. for the device "MODIFICATION TO PLEURX PLEURAL CATHETER AND DRAINAGE KITS". The FDA issued a decision of Substantially Equivalent on June 28, 2001. The device falls under product code DWM (Apparatus, Suction, Patient Care), a Class II device regulated under 21 CFR 870.5050. Denver Biomedical, Inc. has at least 4 other 510(k) clearances on record.