510(k) K873485

EDSLAB (R) OCCLUSION BALLOON CATHETER by American Edwards Laboratories — Product Code DQY

K873485 is an FDA 510(k) premarket notification submitted by American Edwards Laboratories for the device "EDSLAB (R) OCCLUSION BALLOON CATHETER". The FDA issued a decision of Substantially Equivalent on December 3, 1987. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. American Edwards Laboratories has at least 10 other 510(k) clearances on record.