510(k) K923272

COBE CMS-HF HOLLOW FIBER MEMBRANE OXYGENATOR by Cobe Laboratories, Inc. — Product Code DTZ

K923272 is an FDA 510(k) premarket notification submitted by Cobe Laboratories, Inc. for the device "COBE CMS-HF HOLLOW FIBER MEMBRANE OXYGENATOR". The FDA issued a decision of Substantially Equivalent on May 11, 1993. The device falls under product code DTZ (Oxygenator, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4350. Cobe Laboratories, Inc. has at least 10 other 510(k) clearances on record.