510(k) K830637

VERTEX DIGITAL SUBSTRATION KIT by Professional Medical Services — Product Code DQO

K830637 is an FDA 510(k) premarket notification submitted by Professional Medical Services for the device "VERTEX DIGITAL SUBSTRATION KIT". The FDA issued a decision of Substantially Equivalent on March 24, 1983. The device falls under product code DQO (Catheter, Intravascular, Diagnostic), a Class II device regulated under 21 CFR 870.1200. Professional Medical Services has at least 10 other 510(k) clearances on record.