510(k) K000087

MARHUKAR TRIPLE LUMEN CATHETER, MODEL 12 FR by The Kendal Co. — Product Code FOZ

K000087 is an FDA 510(k) premarket notification submitted by The Kendal Co. for the device "MARHUKAR TRIPLE LUMEN CATHETER, MODEL 12 FR". The FDA issued a decision of Substantially Equivalent on March 17, 2000. The device falls under product code FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days), a Class II device regulated under 21 CFR 880.5200. The Kendal Co. has at least 10 other 510(k) clearances on record.