510(k) K904491

TMP LEFT ATRIAL PRESSURE CATH CAT.# 100-00X-000 by Lifestream Int'L, Inc. — Product Code DQO

K904491 is an FDA 510(k) premarket notification submitted by Lifestream Int'L, Inc. for the device "TMP LEFT ATRIAL PRESSURE CATH CAT.# 100-00X-000". The FDA issued a decision of Substantially Equivalent on February 1, 1991. The device falls under product code DQO (Catheter, Intravascular, Diagnostic), a Class II device regulated under 21 CFR 870.1200. Lifestream Int'L, Inc. has at least 10 other 510(k) clearances on record.