510(k) K903021

NEGATIVE PRESSURE ARTERIAL LINE CAT. NO: 03-9630 by National Medical Care, Medical Products Div., Inc. — Product Code FJK

K903021 is an FDA 510(k) premarket notification submitted by National Medical Care, Medical Products Div., Inc. for the device "NEGATIVE PRESSURE ARTERIAL LINE CAT. NO: 03-9630". The FDA issued a decision of Substantially Equivalent on August 14, 1990. The device falls under product code FJK (Set, Tubing, Blood, With And Without Anti-Regurgitation Valve), a Class II device regulated under 21 CFR 876.5820. National Medical Care, Medical Products Div., Inc. has at least 10 other 510(k) clearances on record.