510(k) K915869

RMI NORMOCLUDER CORONARY ARTERY OCCLUDER by Research Medical, Inc. — Product Code MJN

K915869 is an FDA 510(k) premarket notification submitted by Research Medical, Inc. for the device "RMI NORMOCLUDER CORONARY ARTERY OCCLUDER". The FDA issued a decision of Substantially Equivalent on December 8, 1992. The device falls under product code MJN (Catheter, Intravascular Occluding, Temporary), a Class II device regulated under 21 CFR 870.4450. Research Medical, Inc. has at least 10 other 510(k) clearances on record.