510(k) K961495

HUBER NEEDLE EXTENSION SET WITH STANDARD Y-INJECTION SITE, INTERLINK Y-INJECTION SITE, INTERLINK T-INJECTION SITE by Baxter Healthcare Corp — Product Code FPA

K961495 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "HUBER NEEDLE EXTENSION SET WITH STANDARD Y-INJECTION SITE, INTERLINK Y-INJECTION SITE, INTERLINK T-INJECTION SITE". The FDA issued a decision of Substantially Equivalent on Jun 26, 1996. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Baxter Healthcare Corp has 507 other 510(k) clearances on record.