510(k) K122832

MOBICATH TRANSSEPTAL NEEDLE by Great Batch Medical — Product Code DRC

K122832 is an FDA 510(k) premarket notification submitted by Great Batch Medical for the device "MOBICATH TRANSSEPTAL NEEDLE". The FDA issued a decision of Substantially Equivalent on December 19, 2012. The device falls under product code DRC (Trocar), a Class II device regulated under 21 CFR 870.1390. Great Batch Medical has at least 9 other 510(k) clearances on record.