510(k) K971753

DENVER PLEURX PLEURAL CATHETER KIT, CATALOG NO. 50-7000, DENVER PLEURX HOME DRAINAGE KIT, CATALOG NO. 50-7500 by Denver Biomaterials, Inc. — Product Code DWM

K971753 is an FDA 510(k) premarket notification submitted by Denver Biomaterials, Inc. for the device "DENVER PLEURX PLEURAL CATHETER KIT, CATALOG NO. 50-7000, DENVER PLEURX HOME DRAINAGE KIT, CATALOG NO. 50-7500". The FDA issued a decision of Substantially Equivalent (kit) on June 27, 1997. The device falls under product code DWM (Apparatus, Suction, Patient Care), a Class II device regulated under 21 CFR 870.5050. Denver Biomaterials, Inc. has at least 3 other 510(k) clearances on record.