510(k) K032138

MEDTRONIC SINGLE USE ESOPHAGEAL MANOMETRIC CATHETER, MEDTRONIC SINGLE USE ANORECTAL MANOMETRIC CATHETER by Medtronic Vascular — Product Code KLA

K032138 is an FDA 510(k) premarket notification submitted by Medtronic Vascular for the device "MEDTRONIC SINGLE USE ESOPHAGEAL MANOMETRIC CATHETER, MEDTRONIC SINGLE USE ANORECTAL MANOMETRIC CATHETER". The FDA issued a decision of Substantially Equivalent on October 9, 2003. The device falls under product code KLA (Monitor, Esophageal Motility, Anorectal Motility, And Tube), a Class II device regulated under 21 CFR 876.1725. Medtronic Vascular has at least 10 other 510(k) clearances on record.