510(k) K000409

MODIFICATION TO T-REX BIOPSY FORCEPS by Boston Scientific Corp — Product Code DWZ

K000409 is an FDA 510(k) premarket notification submitted by Boston Scientific Corp for the device "MODIFICATION TO T-REX BIOPSY FORCEPS". The FDA issued a decision of Substantially Equivalent on February 28, 2000. The device falls under product code DWZ (Device, Biopsy, Endomyocardial), a Class II device regulated under 21 CFR 870.4075. Boston Scientific Corp has at least 10 other 510(k) clearances on record.