510(k) K023668

JMS EXTENSION SET WITH PLANECTA, PLANECTA (STAND ALONE UNIT), PLANECTA LOCK & PLANECTA ADAPTOR by Jms North America Corp. — Product Code FPA

K023668 is an FDA 510(k) premarket notification submitted by Jms North America Corp. for the device "JMS EXTENSION SET WITH PLANECTA, PLANECTA (STAND ALONE UNIT), PLANECTA LOCK & PLANECTA ADAPTOR". The FDA issued a decision of Substantially Equivalent on July 1, 2003. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Jms North America Corp. has at least 9 other 510(k) clearances on record.