510(k) K082580

SPECTRA GUIDEWIRE INTRODUCER NEEDLE by Spectra Medical Devices, Inc. — Product Code DYB

K082580 is an FDA 510(k) premarket notification submitted by Spectra Medical Devices, Inc. for the device "SPECTRA GUIDEWIRE INTRODUCER NEEDLE". The FDA issued a decision of Substantially Equivalent on December 8, 2008. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Spectra Medical Devices, Inc. has at least 7 other 510(k) clearances on record.