510(k) K981365

MAHURKAR 13.5 FR CUFFED CATHETER WITH CURVED EXTENSIONS by Sherwood Medical Co. — Product Code MSD

K981365 is an FDA 510(k) premarket notification submitted by Sherwood Medical Co. for the device "MAHURKAR 13.5 FR CUFFED CATHETER WITH CURVED EXTENSIONS". The FDA issued a decision of Substantially Equivalent on November 25, 1998. The device falls under product code MSD (Catheter, Hemodialysis, Implanted), a Class II device regulated under 21 CFR 876.5540. Sherwood Medical Co. has at least 10 other 510(k) clearances on record.