510(k) K122587

BRK TRANSSEPTAL NEEDLE MODEL 407200, 407201, 407205, 407206, 407207, G407208 by St Jude Medical — Product Code DRC

K122587 is an FDA 510(k) premarket notification submitted by St Jude Medical for the device "BRK TRANSSEPTAL NEEDLE MODEL 407200, 407201, 407205, 407206, 407207, G407208". The FDA issued a decision of Substantially Equivalent on February 7, 2013. The device falls under product code DRC (Trocar), a Class II device regulated under 21 CFR 870.1390. St Jude Medical has at least 10 other 510(k) clearances on record.