510(k) K881825

MODELS SP5825/SP5835/SP5845/SP5855 PERCU. SHEATH by Spectramed, Inc. — Product Code DYB

K881825 is an FDA 510(k) premarket notification submitted by Spectramed, Inc. for the device "MODELS SP5825/SP5835/SP5845/SP5855 PERCU. SHEATH". The FDA issued a decision of Substantially Equivalent on September 28, 1988. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Spectramed, Inc. has at least 10 other 510(k) clearances on record.