510(k) K080174

PHLEBOTOMY BAG WITH VALVE & 17G X 1, MODEL CM-PH17X1B, CM-PH17X1C by Cardio Med Supplies, Inc. — Product Code LHI

K080174 is an FDA 510(k) premarket notification submitted by Cardio Med Supplies, Inc. for the device "PHLEBOTOMY BAG WITH VALVE & 17G X 1, MODEL CM-PH17X1B, CM-PH17X1C". The FDA issued a decision of Substantially Equivalent on April 23, 2008. The device falls under product code LHI (Set, I.V. Fluid Transfer), a Class II device regulated under 21 CFR 880.5440. Cardio Med Supplies, Inc. has at least 4 other 510(k) clearances on record.