510(k) K052436

PLEURX PLEURAL CATHETER KIT, MODEL 50-7000 by Denver Biomedical, Inc. — Product Code DWM

K052436 is an FDA 510(k) premarket notification submitted by Denver Biomedical, Inc. for the device "PLEURX PLEURAL CATHETER KIT, MODEL 50-7000". The FDA issued a decision of Substantially Equivalent on Oct 6, 2005. 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 4 other 510(k) clearances on record.