510(k) K860805

PRESSURE MONITOR CATH MODELS SP5325,SP5327,SP5337 by Gould, Inc. — Product Code DQO

K860805 is an FDA 510(k) premarket notification submitted by Gould, Inc. for the device "PRESSURE MONITOR CATH MODELS SP5325,SP5327,SP5337". The FDA issued a decision of Substantially Equivalent on May 8, 1986. The device falls under product code DQO (Catheter, Intravascular, Diagnostic), a Class II device regulated under 21 CFR 870.1200. Gould, Inc. has at least 10 other 510(k) clearances on record.