510(k) K940319

R-GROUP INTERNATIONAL COILED LOW PRESSURE EXTENSION LINE by R-Group Intl. — Product Code FPA

K940319 is an FDA 510(k) premarket notification submitted by R-Group Intl. for the device "R-GROUP INTERNATIONAL COILED LOW PRESSURE EXTENSION LINE". The FDA issued a decision of Substantially Equivalent on November 10, 1994. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. R-Group Intl. has at least 6 other 510(k) clearances on record.