510(k) K915109

RAPID ADD SITE DOUBLE LUMEN I.V.EXTENSION SET by Ballard Medical Products — Product Code FPA

K915109 is an FDA 510(k) premarket notification submitted by Ballard Medical Products for the device "RAPID ADD SITE DOUBLE LUMEN I.V.EXTENSION SET". The FDA issued a decision of Substantially Equivalent on May 8, 1992. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Ballard Medical Products has at least 10 other 510(k) clearances on record.